Diamond Diagnostics Inc.

FDA Device Registration & Listing · Budapest, HU · Registration 3006198300

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006198300
FEI Number
3006198300
Entity Name
Diamond Diagnostics Inc.
City/State/Country
Budapest, HU
Establishment Address
6 Oradna Street, Budapest 1044, HU
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Diamond Diagnostics Inc. (Owner Number: 10028706)
Owner / Operator Contact Address
333 Fiske St, Holliston, MA 01746, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K962294
PMA Number
N/A

All Registered Proprietary Names

Chemistry Analyzer Blood Gas Analyzer Chemistry Analyzer Analyzer Analyzer Analyzer Analyzer Immunology Analyzer Analyzer Analyzer Analyzer CD Cal-Packs HEMATOLOGY ANALYZER Analyzer Analyzer Microbiology Analyzer Analyzer SMARTLYTE® Electrolyte Analyzer Analyzer Clinical Chemistry Analyzer Analyzer Analyzer Urine Analyzer Clinical Chemistry BK BUN Linearity Analyzer Clinical Chemistry Analyzer Analyzer Hematology Analyzer Hematology Analyzer CONTROL BK Creatinine CLINCAL CHEMISTRY Analyzer Microbiology Chemistry Analyzer Analyzer Hema CLINCAL CHEMISTRY Clinical Chemistry Analyzer Analyzer Analyzer Clinical Chemistry Analyzer ANALYZER, CHEMISTRY Analyzer Analyzer CONTROL Analyzer HEMATOLOGY ANALYZER Analyzer Analyzer Analyzer Packs Clinical Chemistry SmartLyte URINALYSIS CLINICAL SAMPLE CONCENTRATOR Analyzer Mission Reagents Chemistry Analyzer Hematology Analyzer Photometric Immunology Glucose Test System Assay System Microbiology Coagulation Analyzer Diamond Calibrators for Atac 8000/Envoy 500 ISE Modules Analyzer Hematology Device CALIBRATOR Analyzer PROLYTE Analyzer CLINCAL CHEMISTRY Analyzer Analyzer Chemistry Analyzer Test Systems Analyzer Dade Calibrator HEMATOLOGY ANALYZER Calibrator Hematology Analyzer Hematology Analyzer Analyzer CONTROL Analyzer Analyzer Analyzer Urinalysis Analyzer Controls Analyzer Immunoassay Analyzer Analyzer Hematology Analyzer Hematology Analyzer Analyzer Analyzer Analyzer Urine Analyzer Analyzer Hematology Analyzer Analyzer Chemistry Analyzer Analyzer Hematology Analyzer Cal-Packs Analyzer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2014-07-17
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2014-07-17
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2014-07-17
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2014-07-17
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2014-07-17
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2020-09-01
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2020-09-01
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2020-09-01
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2020-09-01
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2020-09-01
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2020-09-01
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2020-09-01
JPI Device, Hematocrit Measuring Hematology Class 2 864.6400 2020-09-01
GLY Oximeter To Measure Hemoglobin Hematology Class 2 864.7500 2020-09-01
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2020-09-01
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2020-09-01
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2020-09-01
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2025-09-30
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2025-09-30
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2025-09-30
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2025-09-30
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2025-09-30
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2025-09-30
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2025-09-30
GLY Oximeter To Measure Hemoglobin Hematology Class 2 864.7500 2025-09-30
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2025-09-30
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2025-09-30
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2025-09-30
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2025-09-30
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2013-07-12
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2013-07-12
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2011-11-11
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-10
MZA Test, Equipment, Automated Bloodborne Pathogen Unknown Class N N/A 2025-04-28
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2011-11-10
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-11
GKP Instrument, Coagulation, Automated Hematology Class 2 864.5400 2018-03-06
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2009-02-26
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2021-03-18
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-10
GKL Counter, Cell, Automated (Particle Counter) Hematology Class 2 864.5200 2011-11-10
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-14
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2025-09-30
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2025-09-30
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2025-09-30
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2011-11-10
NDW Assay, Porphyrin, Spectrophotometry, Lithium Clinical Toxicology Class 2 862.3560 2011-11-10
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2011-11-10
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2011-11-10
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2011-11-10
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2011-11-10
DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control Immunology Class 2 866.5550 2011-11-10
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2011-11-10
KXS Radioimmunoassay, Methaqualone Clinical Toxicology Class 2 862.3630 2011-11-10
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2011-11-10
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2011-11-10
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2011-11-10
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-10
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2011-11-10
JIF Enzymatic Method, Ammonia Clinical Chemistry Class 1 862.1065 2011-11-10
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2011-11-10
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-10
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2011-11-10
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2011-11-10
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2011-11-10
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2011-11-10
GHH Fibrin Split Products Hematology Class 2 864.7320 2011-11-10
LBZ Enzyme Immunoassay, Quinidine Clinical Toxicology Class 2 862.3320 2011-11-10
DIP Enzyme Immunoassay, Diphenylhydantoin Clinical Toxicology Class 2 862.3350 2011-11-10
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2011-11-10
CJX Acid Phosphatase, Disodium Phenylphosphate Clinical Chemistry Class 2 862.1020 2011-11-10
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2011-11-10
CZP Iga, Antigen, Antiserum, Control Immunology Class 2 866.5510 2011-11-10
KLP Amikacin Serum Assay Clinical Toxicology Class 2 862.3035 2011-11-10
DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control Immunology Class 2 866.5580 2011-11-10
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2011-11-10
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2011-11-10
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2011-11-10
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2011-11-10
CHN Immunochemical, Ceruloplasmin Immunology Class 2 866.5210 2011-11-10
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2011-11-10
DLB Radioimmunoassay, Lsd (125-I) Clinical Toxicology Class 2 862.3580 2011-11-10
KLB Radioimmunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2011-11-10
NDY Test, Cystatin C Clinical Chemistry Class 2 862.1225 2011-11-10
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2011-11-10
LAR Enzyme Immunoassay, Procainamide Clinical Toxicology Class 2 862.3320 2011-11-10
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2011-11-10
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2011-11-10
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2011-11-10
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2011-11-10
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-10
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2011-11-10
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2011-11-10
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2011-11-10
LAN Enzyme Immunoassay, N-Acetylprocainamide Clinical Toxicology Class 2 862.3320 2011-11-10
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2011-11-10
JGQ Turbidimetric, Total Protein Clinical Chemistry Class 2 862.1635 2011-11-10
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2011-11-10
DLZ Enzyme Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2011-11-10
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2011-11-10
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2011-11-10
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2011-11-10
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2011-11-10
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2011-11-10
DKJ Colorimetry, Salicylate Clinical Toxicology Class 2 862.3830 2011-11-10
NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2011-11-10
DAD Haptoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5460 2011-11-10
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2011-11-10
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2011-11-10
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2011-11-10
DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method Clinical Toxicology Class 2 862.3040 2011-11-10
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2011-11-10
JMO Ferrozine (Colorimetric) Iron Binding Capacity Clinical Chemistry Class 1 862.1415 2011-11-10
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 2011-11-10
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2011-11-10
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-10
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2011-11-10
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2011-11-10
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2011-11-10
OAV Mycophenolic Acid Test System Clinical Toxicology Class 2 862.3840 2011-11-10
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-10
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2011-11-10
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2011-11-10
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2011-11-11
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2011-11-11
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2011-11-11
JHR Radioimmunoassay, Immunoglobulins (D, E) Immunology Class 2 866.5510 2011-11-11
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2013-01-10
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2013-01-10
JIH Flame Photometry, Lithium Clinical Toxicology Class 2 862.3560 2013-01-10
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2013-01-10
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2013-01-10
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-15
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2011-11-15
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2011-11-15
KQI Assay, Fetal Hemoglobin Hematology Class 2 864.7455 2011-11-15
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2011-11-15
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2011-11-15
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2011-11-15
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-15
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-15
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-15
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2011-11-15
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2025-09-30
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2025-09-30
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2025-09-30
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2025-09-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2025-09-30
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-11-15
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2011-11-15
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2011-11-15
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2011-11-15
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-15
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-15
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-15
KQI Assay, Fetal Hemoglobin Hematology Class 2 864.7455 2011-11-15
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-11-15
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2011-11-15
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2011-11-15
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-15
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-10
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-10
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-10
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-10
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-11-10
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2014-05-02
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2014-05-02
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2014-05-02
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2014-05-02
LKM Counter, Urine Particle Hematology Class 2 864.5200 2025-09-04
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2025-09-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2025-09-30
CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2009-02-26
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2009-02-26
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-14
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2011-11-14
GLY Oximeter To Measure Hemoglobin Hematology Class 2 864.7500 2011-11-14
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-14
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2011-11-14
CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2025-09-04
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2025-09-04
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2025-09-04
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2025-09-04
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2025-09-04
GLY Oximeter To Measure Hemoglobin Hematology Class 2 864.7500 2025-09-04
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2025-09-04
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2025-09-04
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2025-09-04
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2025-09-04
GKP Instrument, Coagulation, Automated Hematology Class 2 864.5400 2011-11-11
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-11
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2025-09-30
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2018-01-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2020-02-12
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2009-02-26
GGZ Oxyhemoglobin Hematology Class 2 864.7500 2021-08-10
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2021-08-10
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2021-08-10
KHG Whole Blood Hemoglobin Determination Hematology Class 2 864.7500 2021-08-10
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2021-08-10
GGF Acid Hematin Hematology Class 2 864.7500 2021-08-10
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2021-08-10
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2021-08-10
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2021-08-10
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2021-08-10
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2021-08-10
CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2021-08-10
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2011-11-11
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-11
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-11
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2011-11-11
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-11
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2011-11-11
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2023-05-09
OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System Immunology Class 2 866.3860 2023-05-09
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2023-02-01
MYT Biosensor, Immunoassay, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2023-02-01
CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2023-02-01
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2023-02-01
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2023-02-01
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2023-02-01
JFL Ph Rate Measurement, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2023-02-01
CGL Electrode, Ion Based, Enzymatic, Creatinine Clinical Chemistry Class 2 862.1225 2023-02-01
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2023-02-01
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2023-02-01
JPI Device, Hematocrit Measuring Hematology Class 2 864.6400 2023-02-01
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2023-02-01
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2023-02-01
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2023-02-01
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2023-02-01
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2023-02-01
CDO Acid, Uric, Uricase (U.V.) Clinical Chemistry Class 1 862.1775 2011-11-11
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2011-11-11
CHJ Mercuric Thiocyanate, Colorimetry, Chloride Clinical Chemistry Class 2 862.1170 2011-11-11
CKB Acid Phosphatase, Naphthyl Phosphate Clinical Chemistry Class 2 862.1020 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2011-11-11
JMO Ferrozine (Colorimetric) Iron Binding Capacity Clinical Chemistry Class 1 862.1415 2011-11-11
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2011-11-11
DGI Breast Milk, Rhodamine, Antigen, Antiserum, Control Immunology Class 1 866.5170 2011-11-11
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 2011-11-11
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2011-11-11
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2011-11-11
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2011-11-11
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2011-11-11
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2011-11-11
DEF Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control Immunology Class 1 866.5425 2011-11-11
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2011-11-11
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2011-11-11
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2011-11-11
CFQ Radioimmunoassay, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2011-11-11
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2011-11-11
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-11
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2011-11-11
DOD Gas Chromatography, Amphetamine Clinical Toxicology Class 2 862.3100 2011-11-11
JLB Atp And Creatine Kinase (Enzymatic), Creatine Clinical Chemistry Class 1 862.1210 2011-11-11
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2011-11-11
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2011-11-11
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2011-11-11
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-11
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-11
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-11
GKP Instrument, Coagulation, Automated Hematology Class 2 864.5400 2023-09-20
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2020-09-01
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2020-06-12
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia Microbiology Class 1 866.3120 2020-06-12
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2020-06-12
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-15
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2011-11-11
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-10
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-10
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2011-11-10
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-10
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-10
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-11-10
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2025-09-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2025-09-30
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2025-09-30
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2011-11-10
DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Clinical Toxicology Class 2 862.3040 2020-03-27
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2020-03-27
LBZ Enzyme Immunoassay, Quinidine Clinical Toxicology Class 2 862.3320 2020-03-27
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2020-03-27
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 2020-03-27
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2020-03-27
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2020-03-27
DEL Lipoprotein X, Antigen, Antiserum, Control Immunology Class 1 866.5590 2020-03-27
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2020-03-27
LAR Enzyme Immunoassay, Procainamide Clinical Toxicology Class 2 862.3320 2020-03-27
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2020-03-27
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2020-03-27
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2020-03-27
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2020-03-27
JQB Kinetic Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 2020-03-27
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2020-03-27
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2020-03-27
LGI Fluorescence Polarization Immunoassay, Carbamazepine Clinical Toxicology Class 2 862.3645 2020-03-27
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2020-03-27
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2020-03-27
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2020-03-27
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2020-03-27
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2020-03-27
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2020-03-27
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2020-03-27
DLZ Enzyme Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2020-03-27
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2020-03-27
LPT System, Test, Urinary Methylmalonic Acid Clinical Chemistry Class 2 862.1509 2020-03-27
LAN Enzyme Immunoassay, N-Acetylprocainamide Clinical Toxicology Class 2 862.3320 2020-03-27
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2020-03-27
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2020-03-27
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2020-03-27
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2020-03-27
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2020-03-27
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2020-03-27
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2020-03-27
JZW Nephelometer Immunology Class 1 866.4540 2020-03-27
LGQ Fluorescence Polarization Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2020-03-27
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2020-03-27
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2020-03-27
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2020-03-27
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2020-03-27
JXO Enzyme Immunoassay, Cocaine Clinical Toxicology Class 2 862.3250 2020-03-27
CZP Iga, Antigen, Antiserum, Control Immunology Class 2 866.5510 2020-03-27
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2020-03-27
DEW Igg, Antigen, Antiserum, Control Immunology Class 2 866.5510 2020-03-27
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2020-03-27
CET Olive Oil Emulsion (Turbidimetric), Lipase Clinical Chemistry Class 1 862.1465 2020-03-27
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2020-03-27
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2020-03-27
LGS Fluorescence Polarization Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2020-03-27
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2020-03-27
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2020-03-27
MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) Clinical Toxicology Class 2 862.3350 2020-03-27
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2020-03-27
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2020-03-27
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2020-03-27
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2020-03-27
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2020-03-27
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2020-03-27
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2020-03-27
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2020-03-27
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-11
GKL Counter, Cell, Automated (Particle Counter) Hematology Class 2 864.5200 2011-11-11
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2011-11-11
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2011-11-11
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2011-11-11
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2011-11-11
LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) Clinical Toxicology Class 2 862.3350 2011-11-11
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2011-11-11
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2011-11-11
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2011-11-11
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2011-11-11
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2011-11-11
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2011-11-11
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-11
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2011-11-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-11-11
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2011-11-11
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2011-11-11
LGS Fluorescence Polarization Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2011-11-11
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2011-11-11
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
LCR Fluorescent Immunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2011-11-11
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2011-11-11
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2011-11-11
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2011-11-11
LCD Enzyme Immunoassay, Gentamicin Clinical Toxicology Class 2 862.3450 2011-11-11
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2011-11-11
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2011-11-11
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2011-11-11
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2011-11-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2020-02-12
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2020-02-12
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2013-09-04
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2013-09-04
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2013-09-04
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2013-09-04
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2013-09-04
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2013-09-04
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2013-09-04
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2013-09-04
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2013-09-04
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2021-01-25
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2021-01-25
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2021-01-25
GLK Control, Hematocrit Hematology Class 2 864.8625 2021-01-25
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2021-01-25
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2021-01-25
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2021-01-25
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-01-25
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2021-01-25
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2021-01-25
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2021-01-25
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2021-01-25
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2010-09-10
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2011-11-11
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2011-11-11
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2011-11-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2009-02-26
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2025-04-28
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2009-02-26
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2009-02-26
JIH Flame Photometry, Lithium Clinical Toxicology Class 2 862.3560 2009-02-26
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2009-02-26
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2009-02-26
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2021-07-19
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2021-07-19
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2021-07-19
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2021-07-19
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2021-07-19
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2021-07-19
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2021-07-19
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2021-07-19
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2021-07-19
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2021-07-19
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2021-07-19
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2021-07-19
JJH Clinical Sample Concentrator Clinical Chemistry Class 1 862.2310 2021-08-04
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2021-08-04
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-12-12
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-12-12
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-12-12
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2009-02-26
JJG Analyzer, Chemistry, Centrifugal, For Clinical Use Clinical Chemistry Class 1 862.2140 2022-06-21
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2025-03-04
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2022-08-11
JHY Colorimetric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2022-08-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2024-12-27
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2024-12-27
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2025-09-30
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2025-09-30
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2025-09-30
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2025-09-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2025-09-30
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2025-09-30
OEM Human Metapneumovirus (Hmpv) Rna Assay System Microbiology Class 2 866.3980 2024-12-27
OEP Influenza A Virus Subtype Differentiation Nucleic Acid Assay Microbiology Class 2 866.3980 2024-12-27
OZZ Bordetella Pertussis Dna Assay System Microbiology Class 2 866.3980 2024-12-27
OTG Non-Sars Coronavirus Multiplex Nucleic Acid Assay Microbiology Class 2 866.3980 2024-12-27
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2024-12-27
OOU Parainfluenza Multiplex Nucleic Acid Assay Microbiology Class 2 866.3980 2024-12-27
OZX Mycoplasma Pneumoniae Dna Assay System Microbiology Class 2 866.3980 2024-12-27
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2025-09-30
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2011-11-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2013-01-10
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-11
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-11
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-07-24
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2020-02-12
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-14
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2009-02-26
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2009-02-26
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2009-02-26
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2011-11-10
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2020-09-01
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2020-09-01
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2020-09-01
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2020-09-01
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2017-09-07
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2017-09-07
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2017-09-07
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2017-09-07
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-09-07
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2017-09-07
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2017-09-07
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2014-04-28
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2014-04-28
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2014-04-28
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2014-04-28
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2014-04-28
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2020-09-01
JJO Flame Emission Photometer For Clinical Use Clinical Chemistry Class 1 862.2540 2011-11-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2009-02-26
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2020-08-19
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2020-08-19
JFO Fluorometric, Calcium Clinical Chemistry Class 2 862.1145 2020-08-19
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2020-08-19
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2020-08-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2009-02-26
LKM Counter, Urine Particle Hematology Class 2 864.5200 2025-09-04
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2025-09-30
JPD Hemoglobin A2 Quantitation Hematology Class 2 864.7400 2014-05-02
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2020-02-12
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2011-11-10
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-14
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2014-05-02
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2022-04-04
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-02-26
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-11-11
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2025-09-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2025-09-30
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-11
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2011-11-11
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2011-11-11
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2016-04-29
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2025-05-01
QFS Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment Microbiology Class 2 866.3215 2025-05-01
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2010-09-10
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2020-05-28
LKM Counter, Urine Particle Hematology Class 2 864.5200 2020-05-28
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2011-11-11
CFP Radioimmunoassay, Immunoreactive Insulin Clinical Chemistry Class 1 862.1405 2011-11-11
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2011-11-11
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2011-11-11
DIP Enzyme Immunoassay, Diphenylhydantoin Clinical Toxicology Class 2 862.3350 2011-11-11
CGT Radioimmunoassay, Cyclic Gmp Clinical Chemistry Class 2 862.1230 2011-11-11
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2011-11-11
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2011-11-11
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2011-11-11
CGI Radioimmunoassay, Estriol Clinical Chemistry Class 1 862.1265 2011-11-11
JFH Acid Phosphatase (Prostatic), Tartrate Inhibited Clinical Chemistry Class 2 862.1020 2011-11-11
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2011-11-11
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2011-11-11
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2011-11-11
JMM Column Chromatography & Color Development, Hydroxyproline Clinical Chemistry Class 1 862.1400 2011-11-11
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2011-11-11
JHR Radioimmunoassay, Immunoglobulins (D, E) Immunology Class 2 866.5510 2011-11-11
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2011-11-11
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2011-11-11
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2011-11-11
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2011-11-11
DFJ Albumin, Rhodamine, Antigen, Antiserum, Control Immunology Class 2 866.5040 2011-11-11
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2011-11-11
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2011-11-11
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2011-11-11
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2011-11-11
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2011-11-11
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2011-11-11
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 2011-11-11
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2011-11-11
JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2011-11-11
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2011-11-11
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2011-11-11
MSW System, Test, Thyroglobulin Immunology Class 2 866.6010 2011-11-11
LFM Enzyme Immunoassay, Digitoxin Clinical Toxicology Class 2 862.3300 2011-11-11
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2011-11-11
JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin Immunology Class 2 866.5340 2011-11-11
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2011-11-11
CGR Radioimmunoassay, Cortisol Clinical Chemistry Class 2 862.1205 2011-11-11
CKG Radioimmunoassay, Acth Clinical Chemistry Class 2 862.1025 2011-11-11
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2011-11-11
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2011-11-11
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2011-11-11
CEE Radioimmunoassay, Thyroxine-Binding Globulin Clinical Chemistry Class 2 862.1685 2011-11-11
LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Immunology Class 2 866.6010 2011-11-11
JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) Clinical Chemistry Class 1 862.1245 2011-11-11
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
KLT Enzyme Immunoassay, Carbamazepine Clinical Toxicology Class 2 862.3645 2011-11-11
JMF Radioimmunoassay, Human Placental Lactogen Clinical Chemistry Class 2 862.1585 2011-11-11
DGO Ige, Peroxidase, Antigen, Antiserum, Control Immunology Class 2 866.5510 2011-11-11
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2011-11-11
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2011-11-11
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2011-11-11
CFL Radioimmunoassay, Human Growth Hormone Clinical Chemistry Class 1 862.1370 2011-11-11
DHX System, Test, Carcinoembryonic Antigen Immunology Class 2 866.6010 2011-11-11
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2011-11-11
JKD Radioimmunoassay, C-Peptides Of Proinsulin Clinical Chemistry Class 1 862.1135 2011-11-11
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer Immunology Class 2 866.6010 2011-11-11
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2019-01-31
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-11
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2016-06-17
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-14
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2025-09-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2009-02-26
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2011-11-15
JQX Nephelometer, For Clinical Use Clinical Chemistry Class 1 862.2700 2011-11-15

Official Correspondent

Kathy Fisher

US Agent Details

Kathy Fisher Business: DIAMOND DIAGNOSTICS INC. Email: kfisher@diamonddiagnostics.com Phone: (508) 4290450

Related Public Records

Same Entity

Diamond Diagnostics Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003030793 DIAMOND DIAGNOSTICS Inc Holliston, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K840557 Shaban Mfg. Co. REAGENTS & STANDARDS IL 501 NA/K 1984-04-04
K801007 Instrumentation Laboratory CO IL SYSTEM 502 NA/K ANALYZER 1980-05-14
K872302 Ciba Corning Diagnostics Corp. MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER 1987-09-08
K761345 J.T. Baker Chemical Co. GLUCO-HEX TM REAGENT KIT 1977-01-05
K771464 Instrumentation Laboratory CO MULTISTAT III GLUCOSE TEST 1977-09-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0148-2020 Siemens Healthcare Diagnostics, Inc. 2
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0008-06 Abbott Laboratories, Inc 1
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024 Ortho-Clinical Diagnostics, Inc. 1
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06 Beckman Coulter Inc 1
Synchron LX Systems Version 4.5 Operating Software
Z-0010-06 Abbott Laboratories, Inc 1
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

Similar Registrations

Registration Number Establishment Name Location
3012817228 Epocal Inc Ottawa Ontario, CA
3003795116 ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROTKREUZ Zug, CH
9612296 Beckman Coulter Mishima K.K. SUNTO-GUN Shizuoka, JP
9610529 ROCHE DIAGNOSTICS GMBH PENZBERG Bavaria, DE
3015997711 KATMAI INTEGRATED SOLUTIONS Brilliant, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006198300. Last updated year: 2026. Please use registration number 3006198300 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.