Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1181121

FEI Number

1181121

Entity Name

Fisher Diagnostics

City/State/Country

MIDDLETOWN, VA, US

Establishment Address

8365 VALLEY PIKE, MIDDLETOWN, VA 22645, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Thermo Fisher Scientific (Owner Number: 2517925)

Owner / Operator Contact Address

168 Third Avenue, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Microalbumin Alinity c Microalbumin Calibrators Alinity c Microalbumin Reagent Kit Alinity c Microalbumin Controls AxSYM Probe Cleaning Solution Alkaline Phosphatase (TRIS) INR Controls INR Control Plasmas Glucose Standard (200mg/dL) Calcium Standard (10mg/dL) Phosphorus Standard (5.5mg/dL) Carbon Dioxide Standard (25mMol/L) Creatinine Standard (5mg/dL) Chloride Standard (100mm) Bicarbonate Standard, 25mEq/L Magnesium Standard (3.65mg/dL) Prealbumin Creatinine Infinity Creatinine Buffer pH XXX Phosphate-Buffered Saline pH 7.4 pH Control Standards Coagulation Control 3 Coagulation Control Level 3 Thermo Scientific dTIBC Calibrator Total Protein Reagent Alinity c Alkaline Phosphatase Reagent Kit Abbott Clinical Chemistry Alkaline Phosphatase Thromboscreen 200, Instrument GGT (Liquid) Reagent 1 Alinity c Gamma-Glutamyl Transferase Reagent Kit Gamma-Glutamyl Transferase Abbott Clinical Chemistry GGT Abbott Clinical Chemistry Triglycerides Theophylline Standard Alinity c Cholesterol Reagent Kit Abbott Clinical Chemistry Cholesterol Thrombin Time Reagent Activated Alanine Aminotransferase Alinity c Activated Alanine Aminotransferase Reagent Kit Alinity c Immunoglobulin A Reagent Kit HDL Low Control HDL High Control HDL Medium Control Cholinesterase Kit Roche Cell CollectionMedium 945 ML Kit Dispenser for 945 ML RCCM Bottle Kit Roche Cell Collection Medium 20 ML Reference Emulsion Fluid Prealbumin Alinity c Prealbumin Reagent Kit Kontact Reagent Kontact APTT Reagent Olympus Alkaline Phosphatase Iron Standard ARCHITECT ANTI-TPO Immunoassay Reagents Alinity i Anti-TPO Reagent Kit ARCHITECT Anti-TPO Controls ARCHITECT Anti-TPO Calibrators Glucocrush Fruit Punch (50, 75, 100) Glucocrush Orange (50, 75, 100) Glucocrush Lemon-Lime (50, 75, 100) Acid Phosphatase Liquid Stabilizer Acid Phosphatase AUTO CELLINE ISOTON DILUTANTS 1.3% SALINE CS-555 Nerl Blood Bank Saline (20L) Blood Bank Saline (10L) ISOTON DILUTANT Alinity h-series Diluent Infinity ACE Controls Alinity c ICT Sample Diluent Alinity c Activated Aspartate Aminotransferase Reagent Kit Activated Aspartate Aminotransferase Iron / UIBC Calibrators Alinity i Anti-Tg Calibrators Alinity i Anti-TPO Calibrators Alinity i Cortisol Calibrators Alinity i T-Uptake Calibrators Alinity i BRAHMS PCT Calibrators Lactate Dehydrogenase Alinity c Gamma-Glutamyl Transferase Reagent Kit Gamma-Glutamyl Transferase Alinity c Microalbumin Calibrators Blood Bank Saline Nerl Blood Bank Saline D-Dimer Latex Reagent D-Dimer Assay Kit Calcium Architect MPO Reagent Kit Alinity c Albumin BCP Reagent Kit Abbott Clinical Chemistry Albumin BCP DCA/Microalbumin Creatine Control Alinity c Triglyceride Reagent Kit Triglyceride Enzymatic Creatinine Reagent Lipid Controls CEM - ELECTRODE, ION SPECIFIC, POTASSIUM JGS - ELECTRODE, ION SPECIFIC, SODIUM JFP - ELECTRODE, ION SPECIFIC, CALCIUM Alinity c Carbon Dioxide Calibrator Bilirubin Calibrator Multiconstituent Calibrator Alinity c Urine/CSF Protein Calibrator Kit Alinity c Iron Calibrator Kit Alinity i Anti-TPO Controls Carbon Dioxide Calibrator Chloride Sicklescreen Assay Kits Sicklescreen Control Set Alinity c Albumin BCG Reagent Kit Cardiac Enzyme Control Fibrinogen Assay Kit Fibrinogen Reference Plasma Normal Fibrinogen Reference Plasma Imidazole Buffered Saline IBS Diluting Fluid Bovine Thrombin Barbital Buffered Saline Urine/CSF Protein Infinity Glucose Hexokinase Glucose Hexokinase Ammonia Standard Set Infinity BUN/Urea 2 x 125mL Abnormal Thrombin Time Control Low Fibrinogen Control High Fibrinogen Control Alinity c Lactic Acid Reagent Kit Lactate Liquid Lactic Acid Factor VIII Deficient Plasma, immun Architect Troponin-I Reagent Kit Architect Troponin-I Calibrator Kit Magnesium Alinity c Magnesium Reagent Kit Magnesium Arsenazo Normal Control Abnormal Control Clinitek Novus Rinse Additive Kit Clinitek Novus Calibrator Kit DiStat D-Dimer Assay Kit DiStat D-Dimer Control Kit Infinity Amylase Infinity Glucose Oxidase Glucose Oxidase DST Glucose Oxidase Glucose Oxidase LSP Infinity ACE Calibrator ACE CLINICAL CHEMISTRY SYSTEM ACE System Diluent Iron, Liquid Chromogen Reagent Calcium CPC Cell-DYN Emerald Cleaner Alinity c ICT Serum Calibrator Kit Alinity c Bilirubin Calibrator Kit Alinity c Multiconstituent Calibrator Kit Alinity c Carbon Dioxide Calibrator Kit Atellica CH Chemistry Calibrator Urine/CSF Protein Calibrator Aliniity c Iron Calibrator Kit Carbon Dioxide Calibrator (Architect) Multiconstituent Calibrator (Architect) ICT Serum Calibrator Kit Bilirubin Calibrator (Architect) Atellica CH A-LYTE IMT Dilution Check Alinity c Urine/CSF Protein Calibrator Kit ARCHITECT STAT CK-MB I ARCHITECT STAT CK-MB Alinity c Urine/CSF Protein Reagent Kit Urine/CSF Protein AST (GOT) AST (DST) Infinity AST (GOT) RETICULOCYTE Reticulocyte Stain ARCHITECT STAT Myoglobin Controls ARCHITECT STAT CK-MB Controls Thromboscreen 400C Instrument Architect Rubella Control Kit Architect MPO Control Kit Alinity i T-Uptake Controls Alinity c Microalbumin Reagent Kit ARCHITECT B.R.A.H.M.S PCT Controls Calcium Arsenazo III Alinity c Total Protein Reagent Kit Total Protein Reagent Kit Alinity i Cortisol Calibrators Alinity i T-Uptake Calibrators ARCHITECT BRAHMS PCT Calibrators Alinity i Anti-TPO Calibrators Alinity c Urea Nitrogen Reagent Kit Multiple Accessories 95% Dehydrant Isopropanol R40132 Ethanol (95%) 70% Dehydrant R40106 TB Decolorizer (Acid Alcohol) 3% R2470110 Ethanol (70%) Methanol Flex 95 Cell Wash Solution I/NaOH-D 60% Dehydrant CleanCell M 2x2L, Para-Release Spray Isopropyl Alcohol Flex 100 100% Dehydrant R40206 TB Decolorizer (3%) R40134 Acid Ethanol (90%), Methyl Alcohol Flex 80 Acetone Base Mold Release Syntri Safeguard, Flex 100 Fast Flex Kit 1 Ethyl Alcohol 80% Dehydrant Cell Wash Solution I/NaOH-D 2x1, 8L Syntri Safeguard, Isopropyl Alcohol Fast Flex Kit 2 Reagent Alcohol Syntri Safeguard, Dehydrant 100% Clean Cell M 2x2L HE600 Cleaning Kit Alinity c Transferrin Reagent Kit Abbott Clinical Chemistry Transferrin Creatinine Alinity c Creatinine Reagent Kit Olympus CK-NAC Alinity c Lactate Dehydrogenase Reagent Kit Fibrinogen Reagent with Kaolin Alinity c Phosphorus Reagent Kit Phosphorus Buffer 6.838 Wash G/L Zero Reagent Cal G/L Reagent Cleaning Solution 1 and Cleaning Solution 2 (C1/C2) Buffer 7.382 (7.3/CO-ox Zero Buffer) Infinity Uric Acid Uric Acid Glycine Buffered Saline FDP Sample Collection Tubes FDP Positive and Negative Control S FDP Assay Kit FDP Latex Reagent Clinitek Atlas Rinse Additive Clinitek Atlas Calibration Kit Clinitek Atlas Calibrator #4 (Clarity) Alkaline Phosphatase IFCC Alkaline Phosphatase PNPP Alkaline Phosphatase (AMP) Alkaline Phosphatase (AMP) Buffer ALP Alinity c Triglyceride Reagent Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-11-28
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2016-11-28
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2016-11-28
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2015-04-13
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2008-01-08
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-01-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-01-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-01-08
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2018-04-10
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-01-08
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2008-01-08
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2008-01-08
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2008-01-08
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2008-01-08
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2008-01-08
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2008-01-08
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2008-01-08
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2008-01-08
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2008-01-08
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2008-01-08
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2008-01-08
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2008-01-08
JCC	Ph Buffer	Pathology	Class 1	864.4010	1995-09-05
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2008-01-09
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-01-09
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2008-01-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-07-07
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-05-15
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2008-01-08
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2013-01-30
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-05-15
KQG	Instrument, Coagulation	Hematology	Class 2	864.5400	2008-01-09
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2008-01-09
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	1992-12-16
LCY	U.V. Spectrometry, Theophylline	Clinical Toxicology	Class 2	862.3880	2008-01-09
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2013-01-30
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-05-15
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2013-01-30
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2008-01-09
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	1992-12-16
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-01-30
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2013-02-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-09
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2008-01-09
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2019-03-11
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-01-09
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2013-01-30
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-01-09
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2008-01-08
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-01-08
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2006-05-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-05-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2006-05-17
MRV	Drink, Glucose Tolerance	Clinical Chemistry	Class 2	862.1345	2008-02-11
CKB	Acid Phosphatase, Naphthyl Phosphate	Clinical Chemistry	Class 2	862.1020	2008-01-08
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2005-02-24
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2013-01-30
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2023-03-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-01-09
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2018-05-03
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2018-05-03
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2018-05-03
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2016-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-01-08
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-06-27
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2013-01-30
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2013-01-30
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2019-11-26
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2018-04-26
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2017-06-14
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-01-30
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-01-30
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	1998-09-10
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2008-01-09
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2008-01-08
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2008-04-03
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-04-09
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2013-01-30
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2015-01-06
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2018-04-26
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-01-08
CDO	Acid, Uric, Uricase (U.V.)	Clinical Chemistry	Class 1	862.1775	2013-01-30
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2013-01-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-01-30
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-01-09
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2017-11-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2017-11-10
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2017-11-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2017-11-10
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2017-11-10
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Immunology	Class 2	866.5580	2013-01-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-02-24
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Clinical Chemistry	Class 2	862.1170	2008-01-08
GHM	Test, Sickle Cell	Hematology	Class 2	864.7825	2008-01-09
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2013-01-30
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-09
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2013-01-30
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2008-01-09
JGQ	Turbidimetric, Total Protein	Clinical Chemistry	Class 2	862.1635	2013-01-30
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-01-08
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2013-01-30
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-01-08
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2008-01-08
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-01-09
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2008-01-09
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2008-01-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-01-09
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2008-01-09
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2018-12-19
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2008-01-08
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-09
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2015-01-06
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2015-01-06
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2015-01-06
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2015-01-06
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2015-01-06
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2015-01-06
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2015-01-06
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2015-01-06
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2015-01-06
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2015-01-06
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2015-01-06
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2015-01-06
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2008-01-09
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2008-01-08
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-01-09
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-01-30
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-01-08
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2015-11-18
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2008-01-09
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2013-01-30
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2008-01-08
JCB	Detergent	Pathology	Class 1	864.4010	2013-01-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-05-16
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2006-03-02
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2006-03-02
JGQ	Turbidimetric, Total Protein	Clinical Chemistry	Class 2	862.1635	2013-01-30
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2008-01-08
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2013-01-30
GJH	Stain, Reticulocyte	Hematology	Class 1	864.1850	1997-01-28
CFM	Bathophenanthroline, Colorimetry, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2013-01-30
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-24
MZA	Test, Equipment, Automated Bloodborne Pathogen	Unknown	Class N	N/A	2013-02-01
KQG	Instrument, Coagulation	Hematology	Class 2	864.5400	2008-01-09
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2013-01-30
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-01-30
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-04-03
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2008-01-08
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-05-15
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	1992-12-16
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-04-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-06-15
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2013-01-30
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2005-02-24
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2013-01-30
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2016-03-15
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-01-08
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	1992-12-16
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2008-01-09
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2008-01-09
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2017-12-12
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2015-08-28
CDO	Acid, Uric, Uricase (U.V.)	Clinical Chemistry	Class 1	862.1775	2008-01-08
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2008-01-09
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2015-08-28
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2008-01-08
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2018-06-06
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2013-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thermo Fisher Scientific

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010455511	Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd	Suzhou Jiangsu, CN
3006190736	LABOMEX MBP	TIJUANA Baja California, MX
2517925	FISHER SCIENTIFIC COMPANY L.L.C.	PITTSBURGH, PA, US
3006440892	OXOID AUSTRALIA PTY LIMITED	THEBARTON South Australia, AU
1314344	Nalge Nunc International Corporation	Rochester, NY, US

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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2008	Thermo Fisher Scientific	1	Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.

Similar Registrations

Registration Number	Establishment Name	Location
3007652384	MICROBIX	Mississauga Ontario, CA
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
3008514395	Telcare, LLC	Linwood, PA, US
3012118659	ASCENSIA DIABETES CARE HOLDINGS AG	Basel Basel-Stadt, CH
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1181121. Last updated year: 2026. Please use registration number 1181121 when referencing this establishment in official correspondence.