Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1319681

FEI Number

1000136573

Entity Name

ORTHO-CLINICAL DIAGNOSTICS, INC.

City/State/Country

Rochester, NY, US

Establishment Address

100 Indigo Creek Dr, Rochester, NY 14626, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

QuidelOrtho Corporation (Owner Number: 2024674)

Owner / Operator Contact Address

9975 Summers Ridge Road, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VITROS CRP Slides VITROS Calibrator Kit 7 VITROS CHE Slides VITROS Anti-HBe Reagent Pack VITROS Anti-HBe Calibrators VITROS Specialty Diluent VITROS PROT SLides VITROS TP Slides VITROS FS Micro Tips VITROS Versa Tips VITROS Micro Tips VITROS Calibrator Kit 4 VITROS TIBC Kit VITROS Anti-HAV IgM Calibrator VITROS Anti-HAV IgM Controls VITROS Anti-HAV IgM Reagent Pack VITROS INTACT PTH Calibrators VITROS INTACT PTH Reagent Pack VITROS INTACT PTH Range Verifier VITROS LH Reagent Pack VITROS LH Calibrator VITROS HBsAg Confirmatory Kit VITROS HBsAg Calibrator VITROS HBsAg Reagent Pack VITROS CHOL Slides VITROS Immunodiagnostic Products IL-6 Reagent Pack VITROS Immunodiagnostic Products IL-6 Calibrator VITROS Immunodiagnostic Products IL-6 Controls VITROS BENZ Reagent VITROS AMON Slides VITROS Calibrator Kit 5 VITROS AAT Reagent VITROS AAT/HPT Performance Verifiers Ortho Rhhr Control (human & bovine) MTS Diluent 2 ORTHO VERSEIA Pipettor (VERSEIA) ORTHO Summit Processor (OSP) ORTHO VERSEIA Integrated Processor (VIP) ORTHO Confidence System VITROS Calibrator Kit 9 VITROS 5600 Integrated System Refurbished VITROS 5600 Integrated System VITROS PHYT Slides VITROS 5600 Integrated System Certified VITROS Cortisol Calibrator VITROS Cortisol Reagent Pack VITROS Free Thyroid Controls VITROS Total Thyroid Controls VITROS Testosterone Controls VITROS RE Controls VITROS Anemia Controls VITROS Calibrator Kit 14 VITROS TDM Performance Verifiers VITROS TOBRA Reagent VITROS dLDL Reagent VITROS Calibrator Kit 19 VITROS Performance Verifiers VITROS 4600 Chemistry System VITROS Calibrator Kit 19 VITROS 5,1 FS Chemistry System VITROS 5,1 FS Chemistry System Refurbished VITROS 4600 Chemistry System Refurbished MTS Diluent 2 PLUS VITROS MicroSensor Check Fluids VITROS 7% BSA Ortho 7% BSA VITROS Signal Reagent VITROS Reference Fluids VITROS High Sample Diluent A and B VITROS Immuno-Wash Fluid VITROS FS Reconstitution Diluent VITROS Universal Wash Reagent VITROS Urine Electrolyte Diluent VITROS FS Diluent Pack 1, 2, 3 and 4 VITROS Anti-HAV Total Calibrators VITROS Anti-HAV Total Controls VITROS Anti-HAV Total Reagent Pack VITROS Total T4 Calibrator VITROS Total T4 Reagent Pack VITROS NT pro-BNP Reagent Pack VITROS NT pro-BNP Range Verifier VITROS NT pro-BNP Calibrators VITROS HBsAg Controls VITROS PHOS Slides VITROS Total PSA Calibrator VITROS Total PSA Reagent Pack VITROS XT TBIL-ALKP Slides VITROS AFP Reagent Pack VITROS AFP Calibrators VITROS T3 Uptake II Range Verifier VITROS FSH Range Verifier VITROS Progesterone Range Verifier VITROS LH Range Verifier VITROS Total T3 II Range Verifier VITROS Total T4 Range Verifier VITROS Prolactin Range Verifier VITROS Free T3 Range Verifier VITROS DGXN Slides VITROS Immunodiagnostic Products CA 19-9 Reagent Pack VITROS K+ Slides VITROS Liquid Performance Verifiers VITROS AMPH Reagent VITROS Calibrator Kit 8 VITROS ALC Slides ORTHO Bovine Serum Albumin, 22% Protein Concentration ORTHO Bovine Albumin Solution Polymerized VITROS CRBM Slides VITROS TBIL Slides VITROS CREA Slides VITROS XT 7600 Integrated System VITROS XT 7600 Integrated System Certified VITROS XT 3400 Chemistry System VITROS TSH Calibrator VITROS TSH Reagent Pack VITROS 3600 Immunodiagnostics System - Certified VITROS TSH Range Verifier VITROS 3600 Immunodiagnostics System VITROS 3600 Immunodiagnostics System - Refurbished VITROS BuBc Slides VITROS CK Slides VITROS Calibrator Kit 6 VITROS Isoenzyme PVs VITROS CKMB Slides VITROS Immunodiagnostic Products hs Troponin I Low Control VITROS Immunodiagnostic Products hs Troponin I Calibrator VITROS Immunodiagnostic Products hs Troponin I Reagent Pack VITROS Calibrator Kit 13 VITROS GENT Reagent VITROS Calibrator Kit 27 VITROS Calibrator Kit 16 VITROS Immunodiagnostic Products CA 19-9 Calibrator VITROS T3 Uptake II Calibrator VITROS T3 Uptake II Reagent Pack VITROS CAFFN Reagent Kit VITROS Ca Slides VITROS Calibrator Kit 1 VITROS LIPA Slides VITROS UDA Empty Packs VITROS Anti-HIV 1+2 Calibrator VITROS Anti-HIV 1+2 Reagent Pack VITROS Free T3 Calibrator VITROS Free T3 Reagent Pack VITROS METD Reagent VITROS UPRO Performance Verifiers VITROS Calibrator Kit 10 VITROS UPRO Slides VITROS Anti-HBc Controls VITROS 25-OH Vitamin D Total Reagent Pack VITROS 25-OH Vitamin D Total Calibrators VITROS Anti-SARS-CoV-2 IgG Calibrator VITROS Anti-SARS-CoV-2 IgG Reagent Pack VITROS Anti-SARS-CoV-2 IgG Controls VITROS ACET Slides VITROS ApoB Reagent VITROS ApoA1 Reagent VITROS Calibrator Kit 21 VITROS Calibrator Kit 22 VITROS ApoA1 Performance Verifiers VITROS ApoB Performance Verifiers VITROS GGT Slides VITROS Myoglobin Reagent Pack VITROS Myoglobin Range Verifier VITROS Myoglobin Calibrator VITROS Anti-HBc IgM Calibrator VITROS Anti-HBc IgM Reagent Pack VITROS PALB Performance Verifiers VITROS Calibrator Kit 23 VITROS CRP Performance Verifiers VITROS dTIBC Performance Verifiers VITROS Calibrator Kit 29 VITROS dTIBC Reagent VITROS IgA Reagent VITROS IgG Reagent VITROS IgM Reagent VITROS Anti-HBs Quantitative Controls VITROS T4 Calibrator VITROS Free T4 Reagent Pack VITROS Red Cell Folate Pack VITROS Folate Reagent Pack 1/2 VITROS Folate Calibrator VITROS ECiQ Immunodiagnostic System VITROS ECi Immunodiagnostic System Refurbished VITROS ECi Immunodiagnostic System VITROS Percent A1c Performance Verifiers VITROS HbA1c Reagent Kit VITROS Calibrator Kit 31 VITROS PALB Reagent VITROS ALT Slides VITROS ALTV Slides VITROS XT ALTV-AST Slides VITROS ASO Reagent VITROS ASO/RF Performance Verifiers VITROS Calibrator Kit 28 VITROS FSH Calibrator VITROS FSH Reagent Pack VITROS Anti-HBc Reagent Pack VITROS Anti-HBc Calibrator VITROS XT TRIG-CHOL Slides VITROS ECO2 VITROS Cl Slides VITROS GLU Slides VITROS Estradiol Calibrator VITROS Estradiol Reagent Pack ORTHO VISION Analyzer - Certified ORTHO VISION Analyzer ORTHO VISION Max Analyzer VITROS AMYL Slides VITROS Calibrator Kit 17 VITROS Anti-HBc IgM Controls VITROS Progesterone Calibrator Kit VITROS Progesterone Reagent Pack VITROS TRFRN Reagent VITROS Protein Performance Verifiers VITROS Calibrator Kit 20 VITROS Total T3 II Reagent Pack VITROS Total T3 II Calibrator VITROS XT GLU-Ca Slides VITROS Ferritin Reagent Pack VITROS Ferritin Calibrator VITROS CK-MB Range Verifier VITROS Estradiol Range Verifier VITROS Free T4 Range Verifier VITROS Ferritin Range Verifier VITROS BUN/UREA Slides VITROS PHBR Slides VITROS dHDL Slides Ortho Optix Reader VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls DEN210040 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack DEN210040 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040 VITROS Calibrator Kit 11 VITROS VANC Reagent VITROS HCY2 Reagent VITROS HCY2 Performance Verifiers Ortho Coombs Control VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355 VITROS Anti-SARS-CoV-2 IgG Quantitative Controls EUA210322 VITROS Anti-SARS-CoV-2 Total N Controls EUA210355 VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack EUA210322 VITROS Anti-SARS-CoV-2 IgG Quantitative Calibrator EUA210322 VITROS Anti-SARS-CoV-2 Total N Antibody Calibrator EUA210355 VITROS Anti-HCV Calibrators VITROS Anti- HCV Reagent Pack VITROS Total bhCG II Range Verifier VITROS Total bhCG II Reagent Pack VITROS Total bhCG II Calibrator VITROS LAC Slides VITROS HIV Combo Calibrator VITROS HIV Combo Reagent Pack VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack VITROS B12/Folate Reagent Pack 1/2 VITROS B12 Calibrator VITROS B12/Folate Reagent Pack 3 VITROS BRAHMS PCT Range Verifier VITROS BRAHMS PCT Calibrators VITROS BRAHMS PCT Reagent Pack VITROS BRAHMS PCT Controls VITROS THEO Slides VITROS CA 19-9 Range Verifiers VITROS CA 19-9 Calibrator VITROS CA 19-9 Reagent Pack ORTHO T.cruzi ELISA Test System ORTHO Antibody Enhancement Solution VITROS Insulin Calibrator VITROS Insulin Reagent Pack VITROS CEA Calibrators VITROS CEA Reagent Pack VITROS CEA Range Verifier VITROS ALKP Slides VITROS Calibrator Kit 26 VITROS BARB Reagent VITROS DAT Performance Verifiers VITROS ALB-TP Slides ORTHO Workstation VITROS COCM Reagent VITROS Na+ Slides VITROS Total PSA Range Verifier VITROS INTACT PTH Controls VITROS B12 Range Verifier VITROS CA 125 II Range Verifier VITROS Cortisol Range Verifier VITROS CA 15-3 Range Verifier VITROS Metabolism Controls VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers VITROS AFP Range Verifier VITROS Folate Range Verifier VITROS Immunodiagnostic Products hs Troponin I Low Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2022-12-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-15
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2022-12-15
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2023-01-09
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2022-12-19
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2023-01-11
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2024-06-03
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2022-12-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-21
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2022-12-21
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2022-12-15
QLC	Interleukin 6	Unknown	Class N	N/A	2025-05-12
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
JID	Photometric Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2022-12-15
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-19
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2022-12-19
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	2022-12-09
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
MZA	Test, Equipment, Automated Bloodborne Pathogen	Unknown	Class N	N/A	2022-12-09
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2022-12-09
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2022-12-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2022-12-19
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2022-12-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
LDO	Enzymatic Radiochemical Assay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2022-12-19
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2023-02-27
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-02-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-02-27
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2022-12-19
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2022-12-21
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2022-12-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-21
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2022-12-21
MJX	Kit, Serological, Positive Control	Clinical Chemistry	Class 1	862.1660	2023-01-09
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2022-12-15
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2023-01-09
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2023-01-11
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2023-01-11
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Immunology	Class 2	866.6010	2022-12-21
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2023-01-11
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2024-04-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2023-01-11
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-01-11
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2022-12-19
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2022-12-09
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2022-12-21
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2022-12-21
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2022-12-21
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-12-21
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2022-12-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-21
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-12-21
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2022-12-15
JHS	Differential Rate Kinetic Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2022-12-15
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2025-11-26
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-02-17
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2023-01-25
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2022-12-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-15
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2022-12-15
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2022-12-15
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-12-19
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
JGP	Lowry (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2022-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-01-09
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2023-01-09
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2023-05-23
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2022-12-15
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2022-12-19
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2023-01-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2022-12-21
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2023-01-09
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2022-12-19
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2022-12-19
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2022-12-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2022-12-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2022-12-21
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2023-02-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2022-12-19
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2022-12-19
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2022-12-15
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2022-12-19
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2022-12-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2023-01-09
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2023-01-11
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2023-01-11
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2022-12-15
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2022-12-15
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2022-12-15
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2022-12-21
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2025-12-11
CIW	Starch-Dye Bound Polymer, Amylase	Clinical Chemistry	Class 2	862.1070	2022-12-15
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2022-12-21
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2023-01-11
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-01-11
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2022-12-15
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2023-01-11
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2023-01-11
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2026-05-18
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2023-08-21
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2022-12-19
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2022-12-09
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2024-09-11
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2023-01-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2022-12-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-21
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2022-12-15
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2024-06-28
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2022-12-21
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2022-12-21
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2022-12-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-01-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2023-01-09
MIU	Enzyme Linked Immunosorbent Assay, T. Cruzi	Microbiology	Class 1	866.3870	2022-12-09
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2022-12-21
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-12-15
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2023-01-11
KSN	Centrifuge, Cell-Washing, Automated For Immuno-Hematology	Hematology	Class 2	864.9285	2022-12-09
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-11
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-01-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QuidelOrtho Corporation

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
1056600	MICRO TYPING SYSTEMS, INC.	POMPANO BEACH, FL, US
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
1528450	Ortho-Clinical Diagnostics, Inc.	ATHENS, OH, US
2024674	QUIDEL CORP.	SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319681. Last updated year: 2026. Please use registration number 1319681 when referencing this establishment in official correspondence.