Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2250051

FEI Number

2250051

Entity Name

ORTHO-CLINICAL DIAGNOSTICS, INC.

City/State/Country

RARITAN, NJ, US

Establishment Address

1001 US Highway 202, RARITAN, NJ 08869, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K970643

PMA Number

N/A

All Registered Proprietary Names

VITROS Calibrator Kit 16 VITROS RF Reagent VITROS Anti-HBc Reagent Pack VITROS Anti-HBc Calibrator VITROS AMYL Slides VITROS AST Slides VITROS LIPA Slides Quidel Molecular GBS Control Set (M116) VITROS HIV Combo Controls (HIV p24 Antigen) Solana RSV+hMPV Control Set (M123) Quidel Molecular RSV+hMPV Control Set (M107) Solana Influenza A+B Control Set (M122) VITROS Anti-HIV 1+2 Controls Quidel Molecular Adenovirus Control Set (M110) Quidel Molecular Strep A+G Control Set (M111) QuickVue COVID-19 Test Control Swab Set Quidel Molecular Bordetella Control Set (M117) Quidel Molecular Influenza A+B Control Set (M106) Quidel Molecular HSV 1+2/VZV Control Set (M121) Quidel Molecular C. difficile Control Set (M108) Solana HSV 1+2/VZV Control Set (M118) VITROS HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) Quidel Molecular Parainfluenza Virus Control Set (M115) VITROS HIV Combo Controls (Anti-HIV-1 group O) Quidel Molecular HSV 1+2 Control Set (M109) Quidel Molecular Trichomonas Control Set (M119) VITROS LDHI SLides VITROS LDH Slides VITROS CAFFN Reagent Kit VITROS dTIBC Performance Verifiers VITROS Calibrator Kit 29 VITROS dTIBC Reagent VITROS Calibrator Kit 8 VITROS ALC Slides ORTHO T.cruzi ELISA Test System VITROS PCP Reagent VITROS Anti-HIV 1+2 Calibrator VITROS Anti-HIV 1+2 Reagent Pack VITROS PALB Performance Verifiers VITROS Calibrator Kit 23 VITROS HBeAg Calibrator VITROS HBeAg Reagent Pack VITROS TRIG Slides VITROS Na+ Slides VITROS SALI Slides VITROS XT GLU-Ca Slides VITROS BENZ Reagent VITROS FS Micro Tips VITROS Versa Tips VITROS Micro Tips VITROS Cortisol Calibrator VITROS Cortisol Reagent Pack VITROS ALB Slides VITROS Calibrator Kit 4 VITROS Calibrator Kit 99 VITROS Calibrator Kit 2 VITROS Calibrator Kit 32 VITROS Calibrator Kit 3 ORTHO Bovine Serum Albumin, 22% Protein Concentration ORTHO Bovine Albumin Solution Polymerized VITROS Anti-HBs Quantitative Controls VITROS T3 Uptake II Calibrator VITROS T3 Uptake II Reagent Pack VITROS 350 Chemistry System VITROS 250 Chemistry System VITROS 250 Chemistry System Refurbished ORTHO Optix Reader VITROS AMON Slides VITROS Calibrator Kit 5 ORTHO Antibody Enhancement Solution VITROS Calibrator Kit 12 VITROS VALP Reagent 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 VITROS K+ Slides VITROS TRFRN Reagent VITROS Protein Performance Verifiers VITROS Calibrator Kit 20 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 C3 Reagent VITROS C4 Reagent VITROS ECiQ Immunodiagnostic System VITROS ECi Immunodiagnostic System Refurbished VITROS ECi Immunodiagnostic System Ortho Optix Reader VITROS Total T4 Calibrator VITROS Total T4 Reagent Pack VITROS dLDL Reagent VITROS Calibrator Kit 19 VITROS Performance Verifiers VITROS CHE Slides VITROS Anti-HCV Controls ORTHO VISION Analyzer - Certified ORTHO VISION Analyzer ORTHO VISION Max Analyzer VITROS CRP Slides VITROS Calibrator Kit 7 VITROS FSH Calibrator VITROS FSH Reagent Pack DAT Control, MTS DAT Card VITROS CK-MB Calibrator VITROS CK-MB Reagent Pack VITROS Calibrator Kit 13 VITROS GENT Reagent VITROS INTACT PTH Calibrators VITROS INTACT PTH Reagent Pack VITROS INTACT PTH Range Verifier Ortho Rhhr Control (human & bovine) VITROS Anti-HBe Reagent Pack VITROS Anti-HBe Calibrators VITROS ASO Reagent VITROS ASO/RF Performance Verifiers VITROS Calibrator Kit 28 VITROS Calibrator Kit 9 VITROS 5600 Integrated System Refurbished VITROS 5600 Integrated System VITROS PHYT Slides VITROS 5600 Integrated System Certified VITROS Calibrator Kit 14 VITROS TDM Performance Verifiers VITROS TOBRA Reagent VITROS PALB Reagent VITROS Myoglobin Reagent Pack VITROS Myoglobin Range Verifier VITROS Myoglobin Calibrator VITROS 25-OH Vitamin D Total Reagent Pack VITROS 25-OH Vitamin D Total Calibrators VITROS Calibrator Kit 30 VITROS FS Calibrator 1 VITROS THC Reagent VITROS Calibrator Kit 1 VITROS Mg Slides 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 PROT SLides VITROS TP Slides VITROS dHDL Slides MTS Diluent 2 VITROS AAT Reagent VITROS AAT/HPT Performance Verifiers VITROS AMPH Reagent VITROS NT-proBNP II Reagent Pack VITROS Testosterone Range Verifier VITROS Testosterone Reagent Pack VITROS Testosterone Calibrator VITROS Troponin I ES Calibrators VITROS Troponin I ES Reagent Pack VITROS Troponin I ES Range Verifier VITROS Immunodiagnostic Products CEA Reagent Pack VITROS Immunodiagnostic Products CEA Calibrators VITROS HIV Combo Calibrator VITROS HIV Combo Reagent Pack VITROS BRAHMS PCT Range Verifier VITROS BRAHMS PCT Calibrators VITROS BRAHMS PCT Reagent Pack VITROS BRAHMS PCT Controls VITROS Anti-HBc Controls VITROS Immunodiagnostic Products Intact PTH II Calibrators VITROS Immunodiagnostic Products Intact PTH II Reagent Pack VITROS Chemistry Products dHDL Slides VITROS Chemistry Products Calibrator Kit 25 VITROS Chemistry Products Performance Verifiers VITROS BUN/UREA Slides VITROS Total bhCG II Range Verifier VITROS Total bhCG II Reagent Pack VITROS Total bhCG II Calibrator VITROS Red Cell Folate Pack VITROS Folate Reagent Pack 1/2 VITROS Folate Calibrator VITROS CK Slides VITROS Calibrator Kit 6 VITROS Isoenzyme PVs VITROS CKMB Slides VITROS URIC Slides QuickVue At Home COVID-19 Sofia SARS Antigen FIA Sofia 2 SARS Antigen FIA QuickVue SARS Antigen Test VITROS SARS-COV-2 Antigen Reagent Pack EUA202928 VITROS SARS-COV-2 Antigen Calibrator EUA202928 VITROS SARS-COV-2 Antigen Controls EUA202928 VITROS SARS-COV-2 Extraction Buffer EUA202928 VITROS Liquid Performance Verifiers VITROS DGXN Slides VITROS Calibrator Kit 26 VITROS BARB Reagent VITROS DAT Performance Verifiers VITROS Total PSA Calibrator VITROS Total PSA Reagent Pack VITROS CA 19-9 Range Verifiers VITROS CA 19-9 Calibrator VITROS CA 19-9 Reagent Pack VITROS Anti-HBc IgM Calibrator VITROS Anti-HBc IgM Reagent Pack VITROS Calibrator Kit 4 VITROS TIBC Kit VITROS Calibrator Kit 17 VITROS BuBc Slides VITROS Prolactin Reagent Pack VITROS Prolactin Calibrator VITROS Calibrator Kit 27 VITROS Calibrator Kit 16 VITROS Immunodiagnostic Products CA 19-9 Calibrator Ortho Anti A1 Lectin VITROS NTx Range Verifier VITROS Immunodiagnostic Products CA 19-9 Reagent Pack VITROS Anti-SARS-CoV-2 IgG Calibrator VITROS Anti-SARS-CoV-2 IgG Reagent Pack VITROS Anti-SARS-CoV-2 IgG Controls VITROS Fe Slides VITROS ACET Slides VITROS Ca Slides VITROS Calibrator Kit 1 ORTHO Confidence System VITROS Anti-HBs Quantitative Reagent Pack VITROS Anti-HBs Quantitative Calibrators VITROS Calibrator Kit 11 VITROS VANC Reagent ORTHO VERSEIA Pipettor (VERSEIA) ORTHO Summit Processor (OSP) ORTHO VERSEIA Integrated Processor (VIP) ORTHO Workstation VITROS NT pro-BNP Reagent Pack VITROS NT pro-BNP Range Verifier VITROS NT pro-BNP Calibrators VITROS HBsAg Controls 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 CK-MB Range Verifier VITROS Estradiol Range Verifier VITROS Free T4 Range Verifier VITROS Ferritin Range Verifier VITROS Estradiol Calibrator VITROS Estradiol Reagent Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2022-12-19
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
CIW	Starch-Dye Bound Polymer, Amylase	Clinical Chemistry	Class 2	862.1070	2022-12-15
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2022-12-15
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2022-12-15
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2022-12-21
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2022-12-15
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
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
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2022-12-19
MIU	Enzyme Linked Immunosorbent Assay, T. Cruzi	Microbiology	Class 1	866.3870	2022-12-09
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
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
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	2022-12-15
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
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2022-12-15
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
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
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2024-06-03
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
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2022-12-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-19
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2022-12-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2023-01-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-02-27
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2022-12-09
JID	Photometric Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2022-12-15
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	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	2022-12-21
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
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
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2024-09-11
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	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
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2022-12-19
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2023-02-27
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2026-05-18
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	2022-12-19
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
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2022-12-15
MJX	Kit, Serological, Positive Control	Clinical Chemistry	Class 1	862.1660	2023-01-09
MJY	Kit, Serological, Negative Control	Clinical Chemistry	Class 1	862.1660	2023-01-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2025-12-11
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
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
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2025-12-08
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2022-12-21
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	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
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	2022-12-09
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
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2022-12-19
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
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
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2022-12-19
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
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
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	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
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2022-12-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-15
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
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2023-01-11
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2023-01-11
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
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
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
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2025-03-25
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2022-12-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-21
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2022-12-21
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	2023-12-14
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2023-12-14
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2024-04-02
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2024-04-02
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-04-02
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2022-12-15
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
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
JHS	Differential Rate Kinetic Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2022-12-15
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2023-01-11
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-11-24
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2023-01-11
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
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2023-01-09
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
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
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
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
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2022-12-15
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2022-12-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-02-17
KSI	Lectins And Protectins	Hematology	Class 2	864.9550	2022-12-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	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	2024-04-02
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2023-05-23
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2022-12-15
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2022-12-15
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
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2022-12-09
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-11
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	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
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2022-12-19
MZA	Test, Equipment, Automated Bloodborne Pathogen	Unknown	Class N	N/A	2022-12-09
KSN	Centrifuge, Cell-Washing, Automated For Immuno-Hematology	Hematology	Class 2	864.9285	2022-12-09
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
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
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
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	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
1528450	Ortho-Clinical Diagnostics, Inc.	ATHENS, OH, US
2024674	QUIDEL CORP.	SAN DIEGO, CA, US
3012963943	Ortho Clinical Diagnostics, K.K.	Shinagawa-ku Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852783	Advanced Biomedical Methods, Inc.	SGOT/ALT REAGENT	1985-07-22
K842244	Diagnostic Chemicals, Ltd. (Usa)	LACTATE DENYDRO GENASE ASSAY KIT	1984-07-18
K803039	General Diagnostics	PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.	1980-12-22
K011166	Syva Co., Dade Behring, Inc.	MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229	2001-05-10
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Z-0032-2014	Bio-Rad Laboratories	2	FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Z-0102-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
Z-0103-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
Z-0006-2015	ELITech Clinical Systems SAS Zone lndustrielle SEES France	2	ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Similar Registrations

Registration Number	Establishment Name	Location
9610746	BIOKIT S.A.	LLISSA D AMUNT Barcelona, ES
3022178699	IMMUNOCENTRIX CORPORATION	Canoga Park, CA, US
9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2250051. Last updated year: 2026. Please use registration number 2250051 when referencing this establishment in official correspondence.