Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012963943

FEI Number

3012963943

Entity Name

Ortho Clinical Diagnostics, K.K.

City/State/Country

Shinagawa-ku Tokyo, JP

Establishment Address

East Tower 16F, GateCilty Osaki, Osaki 1-11-2,, Ortho Care Technical Support Center, Shinagawa-ku Tokyo 141-0032, JP

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

K120609

PMA Number

N/A

All Registered Proprietary Names

VITROS Total PSA Calibrator VITROS Total PSA Reagent Pack ORTHO Bovine Serum Albumin, 22% Protein Concentration ORTHO Bovine Albumin Solution Polymerized VITROS AMON Slides VITROS Calibrator Kit 5 VITROS Red Cell Folate Pack VITROS Folate Reagent Pack 1/2 VITROS Folate Calibrator 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 ORTHO Antibody Enhancement Solution VITROS Free T3 Calibrator VITROS Free T3 Reagent Pack VITROS PHBR Slides VITROS Calibrator Kit 9 VITROS 5600 Integrated System Refurbished VITROS 5600 Integrated System VITROS PHYT Slides VITROS 5600 Integrated System Certified VITROS FS Micro Tips VITROS Versa Tips VITROS Micro Tips VITROS T3 Uptake II Calibrator VITROS T3 Uptake II Reagent Pack VITROS IgA Reagent VITROS IgG Reagent VITROS IgM Reagent VITROS LDHI SLides VITROS LDH Slides VITROS PALB Reagent VITROS Total T3 II Reagent Pack VITROS Total T3 II Calibrator ORTHO Confidence System VITROS K+ Slides VITROS AMYL Slides VITROS XT UREA-CREA Slides 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 25-OH Vitamin D Total Reagent Pack VITROS 25-OH Vitamin D Total Calibrators VITROS METD Reagent DAT Control, MTS DAT Card 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 Calibrator Kit 13 VITROS GENT Reagent ORTHO Workstation Ortho Optix Reader VITROS XT TBIL-ALKP Slides VITROS DGXN Slides VITROS Anti-HCV Calibrators VITROS Anti- HCV 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 Calibrator Kit 16 VITROS RF Reagent VITROS PCP Reagent 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 VITROS CK-MB Range Verifier VITROS Estradiol Range Verifier VITROS Free T4 Range Verifier VITROS Ferritin Range Verifier VITROS AST Slides VITROS HBsAg Controls VITROS ApoB Reagent VITROS ApoA1 Reagent VITROS Calibrator Kit 21 VITROS Calibrator Kit 22 VITROS ApoA1 Performance Verifiers VITROS ApoB Performance Verifiers VITROS Anti-HAV Total Calibrators VITROS Anti-HAV Total Controls VITROS Anti-HAV Total Reagent Pack VITROS Troponin I ES Calibrators VITROS Troponin I ES Reagent Pack VITROS Troponin I ES Range Verifier VITROS BuBc Slides VITROS Anti-HBc IgM Calibrator VITROS Anti-HBc IgM Reagent Pack VITROS Calibrator Kit 27 VITROS Calibrator Kit 16 VITROS Immunodiagnostic Products CA 19-9 Calibrator VITROS ACET Slides VITROS CA 15-3 Calibrator VITROS CA 15-3 Reagent Pack VITROS Total bhCG II Range Verifier VITROS Total bhCG II Reagent Pack VITROS Total bhCG II Calibrator VITROS Cortisol Calibrator VITROS Cortisol Reagent Pack VITROS XT TRIG-CHOL Slides VITROS Percent A1c Performance Verifiers VITROS HbA1c Reagent Kit VITROS Calibrator Kit 31 VITROS BENZ Reagent VITROS Calibrator Kit 11 VITROS VANC Reagent VITROS CA 125 II Calibrator VITROS CA 125 II Reagent Pack VITROS LAC Slides VITROS NT-proBNP II Reagent Pack VITROS AMPH Reagent VITROS Anti-HBs Quantitative Controls VITROS CAFFN Reagent Kit VITROS Myoglobin Reagent Pack VITROS Myoglobin Range Verifier VITROS Myoglobin Calibrator MTS Diluent 2 VITROS ASO Reagent VITROS ASO/RF Performance Verifiers VITROS Calibrator Kit 28 VITROS AAT Reagent VITROS AAT/HPT Performance Verifiers 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 C3 Reagent VITROS C4 Reagent VITROS Calibrator Kit 8 VITROS ALC Slides VITROS HPT Reagent VITROS Testosterone Range Verifier VITROS Testosterone Reagent Pack VITROS Testosterone Calibrator VITROS HBeAg Calibrator VITROS HBeAg Reagent Pack 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 Immunodiagnostic Products Intact PTH II Calibrators VITROS Immunodiagnostic Products Intact PTH II Reagent Pack VITROS T4 Calibrator VITROS Free T4 Reagent Pack VITROS CHE Slides VITROS Ca Slides VITROS Calibrator Kit 1 VITROS OP Reagent ORTHO Optix Reader 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 Anti-HIV 1+2 Calibrator VITROS Anti-HIV 1+2 Reagent Pack 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 HIV Combo Calibrator VITROS HIV Combo Reagent Pack VITROS URIC Slides VITROS PALB Performance Verifiers VITROS Calibrator Kit 23 VITROS BRAHMS PCT Range Verifier VITROS BRAHMS PCT Calibrators VITROS BRAHMS PCT Reagent Pack VITROS BRAHMS PCT Controls VITROS NT pro-BNP Reagent Pack VITROS NT pro-BNP Range Verifier VITROS NT pro-BNP Calibrators VITROS Na+ Slides VITROS Chemistry Products dHDL Slides VITROS Chemistry Products Calibrator Kit 25 VITROS Chemistry Products Performance Verifiers VITROS Calibrator Kit 14 VITROS TDM Performance Verifiers VITROS TOBRA Reagent VITROS Anti-HBc Reagent Pack VITROS Anti-HBc Calibrator VITROS 350 Chemistry System VITROS 250 Chemistry System VITROS 250 Chemistry System Refurbished VITROS INTACT PTH Calibrators VITROS INTACT PTH Reagent Pack VITROS INTACT PTH Range Verifier VITROS Calibrator Kit 30 VITROS FS Calibrator 1 VITROS THC Reagent Ortho Rhhr Control (human & bovine) VITROS Anti-HBc Controls VITROS XT GLU-Ca Slides VITROS CA 19-9 Range Verifiers VITROS CA 19-9 Calibrator VITROS CA 19-9 Reagent Pack VITROS Immunodiagnostic Products CA 19-9 Reagent Pack VITROS Anti-HBe Reagent Pack VITROS Anti-HBe Calibrators 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 Anti-HAV IgM Calibrator VITROS Anti-HAV IgM Controls VITROS Anti-HAV IgM Reagent Pack VITROS Calibrator Kit 26 VITROS BARB Reagent VITROS DAT Performance Verifiers VITROS Immunodiagnostic Products CEA Reagent Pack VITROS Immunodiagnostic Products CEA Calibrators VITROS dHDL Slides

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2023-01-09
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2022-12-09
JID	Photometric Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2022-12-15
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2023-01-11
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
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2024-06-03
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2023-01-25
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
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2022-12-15
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2022-12-19
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2022-12-21
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2022-12-09
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
CIW	Starch-Dye Bound Polymer, Amylase	Clinical Chemistry	Class 2	862.1070	2022-12-15
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2023-01-11
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2023-01-11
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2024-09-11
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
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
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2025-12-08
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2022-12-19
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
KSN	Centrifuge, Cell-Washing, Automated For Immuno-Hematology	Hematology	Class 2	864.9285	2022-12-09
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2026-05-18
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
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2023-01-11
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2023-01-09
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2023-05-23
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2022-12-19
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
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2022-12-15
MJX	Kit, Serological, Positive Control	Clinical Chemistry	Class 1	862.1660	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
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2022-12-19
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	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
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2022-12-15
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
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-02-17
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2022-12-15
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	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
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
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
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
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
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
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2023-01-09
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2022-12-15
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2025-03-25
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
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
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
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2022-12-19
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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
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
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2022-12-19
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2022-12-19
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
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-11-24
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2023-12-14
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2022-12-21
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	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
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2022-12-09
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2022-12-21
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
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
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2023-01-11
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
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	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
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
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
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
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
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	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
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
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	2022-12-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
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
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
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2024-04-02
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
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2023-08-21
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2022-12-21
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
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2023-12-14
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2023-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

Marlene Hanna Business: Ortho-Clinical Diagnostics, Inc. Email: marlene.hanna@quidelortho.com Phone: (585) 4534041

Related Public Records

Same Entity

QuidelOrtho Corporation

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

View Entity Profile →

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
K172201	Siemens Healthcare Diagnostics, Inc.	Atellica IM Folate Assay	2018-04-12
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-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-0030-2013	Siemens Healthcare Diagnostics, Inc.	2	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

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9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3008344661	ABBOTT IRELAND	SLIGO, IE
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 3012963943. Last updated year: 2026. Please use registration number 3012963943 when referencing this establishment in official correspondence.