Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000308930

FEI Number

3000308930

Entity Name

Ortho-Clinical Diagnostics European Support Center

City/State/Country

Illkirch, CEDEX Bas-Rhin, FR

Establishment Address

1500 Boulevard Sebastien Brant, B.P. 30335, Illkirch, CEDEX Bas-Rhin 67411, FR

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

K052867

PMA Number

N/A

All Registered Proprietary Names

VITROS Immunodiagnostic Products CA 19-9 Reagent Pack Ortho Optix Reader 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 Liquid Performance Verifiers 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 30 VITROS FS Calibrator 1 VITROS THC Reagent VITROS HBeAg Calibrator VITROS HBeAg Reagent Pack Ortho Rhhr Control (human & bovine) VITROS Troponin I ES Calibrators VITROS Troponin I ES Reagent Pack VITROS Troponin I ES Range Verifier 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 Ortho Coombs Control VITROS XT TBIL-ALKP Slides ORTHO Workstation VITROS Anti-HBc Controls VITROS NTx Range Verifier VITROS BRAHMS PCT Range Verifier VITROS BRAHMS PCT Calibrators VITROS BRAHMS PCT Reagent Pack VITROS BRAHMS PCT Controls ORTHO Antibody Enhancement Solution VITROS Calibrator Kit 4 VITROS TIBC Kit VITROS hsCRP Performance Verifiers VITROS hsCRP Reagent 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 Na+ Slides VITROS CRP Performance Verifiers MTS Diluent 2 PLUS VITROS PHBR Slides VITROS Fe Slides VITROS Anti-HBc IgM Controls VITROS CA 125 II Calibrator VITROS CA 125 II Reagent Pack VITROS Calibrator Kit 16 VITROS RF Reagent VITROS CK-MB Calibrator VITROS CK-MB Reagent Pack VITROS ECiQ Immunodiagnostic System VITROS ECi Immunodiagnostic System Refurbished VITROS ECi Immunodiagnostic System VITROS 350 Chemistry System VITROS 250 Chemistry System VITROS 250 Chemistry System Refurbished VITROS PCP Reagent VITROS TRIG Slides VITROS IgA Reagent VITROS IgG Reagent VITROS IgM Reagent VITROS Calibrator Kit 8 VITROS ALC Slides VITROS CHE Slides VITROS AST Slides VITROS OP Reagent VITROS Calibrator Kit 24 VITROS mALB Performance Verifiers VITROS mALB Reagent VITROS Calibrator Kit 12 VITROS VALP Reagent VITROS Chemistry Products dHDL Slides VITROS Chemistry Products Calibrator Kit 25 VITROS Chemistry Products Performance Verifiers VITROS Total T4 Calibrator VITROS Total T4 Reagent Pack VITROS HPT Reagent Ortho Anti A1 Lectin VITROS PALB Reagent VITROS Calibrator Kit 26 VITROS BARB Reagent VITROS DAT Performance Verifiers VITROS dHDL Slides VITROS XT UREA-CREA Slides VITROS Anti-HBs Quantitative Controls VITROS PALB Performance Verifiers VITROS Calibrator Kit 23 VITROS Progesterone Calibrator Kit VITROS Progesterone 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 Li Slides VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack VITROS Calibrator Kit 27 VITROS Calibrator Kit 16 VITROS Immunodiagnostic Products CA 19-9 Calibrator VITROS C3 Reagent VITROS C4 Reagent 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 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 AMPH Reagent VITROS AMON Slides VITROS Calibrator Kit 5 VITROS Total T3 II Reagent Pack VITROS Total T3 II Calibrator 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 Anti-HCV Controls VITROS CEA Calibrators VITROS CEA Reagent Pack VITROS CEA Range Verifier VITROS Prolactin Reagent Pack VITROS Prolactin Calibrator ORTHO Optix Reader VITROS FSH Calibrator VITROS FSH Reagent Pack 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 ALB-TP Slides VITROS Calibrator Kit 17 VITROS K+ Slides 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 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 ASO Reagent VITROS ASO/RF Performance Verifiers VITROS Calibrator Kit 28 VITROS THEO Slides VITROS Anti-HBs Quantitative Reagent Pack VITROS Anti-HBs Quantitative Calibrators VITROS XT TRIG-CHOL Slides VITROS Calibrator Kit 99 VITROS Calibrator Kit 2 VITROS Calibrator Kit 32 VITROS Calibrator Kit 3 VITROS HBsAg Confirmatory Kit VITROS HBsAg Calibrator VITROS HBsAg Reagent Pack VITROS Calibrator Kit 9 VITROS 5600 Integrated System Refurbished VITROS 5600 Integrated System VITROS PHYT Slides VITROS 5600 Integrated System Certified VITROS METD Reagent VITROS Ca Slides VITROS Calibrator Kit 1 VITROS Anti-HIV 1+2 Calibrator VITROS Anti-HIV 1+2 Reagent Pack VITROS LAC Slides VITROS Calibrator Kit 1 VITROS Mg Slides VITROS Anti-HAV IgM Calibrator VITROS Anti-HAV IgM Controls VITROS Anti-HAV IgM Reagent Pack VITROS Calibrator Kit 14 VITROS TDM Performance Verifiers VITROS TOBRA Reagent VITROS INTACT PTH Calibrators VITROS INTACT PTH Reagent Pack VITROS INTACT PTH Range Verifier VITROS AAT Reagent VITROS AAT/HPT Performance Verifiers VITROS Calibrator Kit 13 VITROS GENT Reagent VITROS BENZ Reagent VITROS Myoglobin Reagent Pack VITROS Myoglobin Range Verifier VITROS Myoglobin Calibrator VITROS Anti-HBc Reagent Pack VITROS Anti-HBc Calibrator VITROS Immunodiagnostic Products hsTroponin I Calibrator VITROS Calibrator Kit 25 VITROS Immunodiagnostic Products Progesterone 2 Calibrators VITROS NT-proBNP II Reagent Pack ORTHO Bovine Serum Albumin, 22% Protein Concentration ORTHO Bovine Albumin Solution Polymerized DAT Control, MTS DAT Card VITROS AMYL Slides VITROS ACET Slides VITROS CAFFN Reagent Kit MTS Diluent 2 VITROS dTIBC Performance Verifiers VITROS Calibrator Kit 29 VITROS dTIBC Reagent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2024-04-02
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2026-05-18
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
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2023-05-23
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
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	2022-12-09
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
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2024-09-11
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2022-12-09
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
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	2023-01-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2022-12-21
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
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
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2022-12-19
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-11-24
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
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2022-12-19
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2023-01-11
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2022-12-15
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2023-01-09
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2022-12-19
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2022-12-21
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2023-02-27
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-02-27
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
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2022-12-15
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
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2022-12-19
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2022-12-15
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	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
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
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2022-12-19
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
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
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
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2022-12-19
KSI	Lectins And Protectins	Hematology	Class 2	864.9550	2022-12-09
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2022-12-19
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
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2023-01-11
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	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
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
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
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2022-12-15
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2024-06-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-02-17
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
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
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
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
JID	Photometric Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2022-12-15
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2022-12-21
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
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
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
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2022-12-21
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2022-12-09
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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2023-01-11
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
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
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2022-12-19
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
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2022-12-19
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2022-12-15
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
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
JIX	Calibrator, Multi-Analyte Mixture	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
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
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
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
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2022-12-15
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
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	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
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
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
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
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
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
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-19
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2025-03-25
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2022-12-09
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2025-12-08
CIW	Starch-Dye Bound Polymer, Amylase	Clinical Chemistry	Class 2	862.1070	2022-12-15
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	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
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
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

Official Correspondent

No official correspondent registered.

US Agent Details

Raquel Almeida Business: Ortho-Clinical Diagnostics, Inc. Email: orthocompliance@quidelortho.com Phone: (908) 7046825

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
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25
K151792	Siemens Healthcare Diagnostics, Inc.	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System	2015-11-20
K141999	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR TSH	2015-04-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
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.

Similar Registrations

Registration Number	Establishment Name	Location
3007111389	Ortho-Clinical Diagnostics	Pencoed Bridgend, GB
1219913	Siemens Healthcare Diagnostics Inc.	E Walpole, MA, US
8020888	Siemens Healthcare Diagnostics Manufacturing Ltd.	SWORDS Dublin, IE
3005529799	TOSOH BIOSCIENCE, INC.	Grove City, OH, US
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 3000308930. Last updated year: 2026. Please use registration number 3000308930 when referencing this establishment in official correspondence.