FDA Registration
Active
🇺🇸 United States
ORTHO-CLINICAL DIAGNOSTICS, INC.
Reg #: 1319809
·
FEI: 1000305840
·
Expires 2026
Products
50
Proprietary Names
75
Establishment Types
2
Classifications
50
Registration Details
- Registration Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Registration Number
- 1319809
- FEI Number
- 1000305840
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 513 Technology Blvd.
- City
- ROCHESTER
- State
- NY
- ZIP
- 14626
- Country
- US
Regulatory Submissions
- 510(k) Number
- K946090
Owner / Operator
- Firm Name
- QuidelOrtho Corporation
- Operator Number
- 2024674
- Address
- 9975 Summers Ridge Road
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Urease, Photometric, Urea Nitrogen | CDN | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2023-01-31 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Flame Photometry, Lithium | JIH | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Lowry (Colorimetric), Total Protein | JGP | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2023-01-31 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2023-01-11 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2022-12-21 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2024-04-02 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2024-04-02 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Starch-Dye Bound Polymer, Amylase | CIW | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Photometric Method, Ammonia | JID | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2022-12-15 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2022-12-15 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2023-01-11 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Differential Rate Kinetic Method, Cpk Or Isoenzymes | JHS | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Bromcresol Purple Dye-Binding, Albumin | CJW | Class 2 | Clinical Chemistry | No | 2026-06-12 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2022-12-15 |
Proprietary Names
VITROS ALKP Slides
VITROS XT UREA-CREA Slides
VITROS ALT2 Slides
VITYROS XT ALT2-ASTJ Slides
VITROS XT GLU-Ca Slides
VITROS Li Slides
VITROS PHOS Slides
VITROS AST Slides
VITROS SALI Slides
VITROS Calibrator Kit 9
VITROS 5600 Integrated System Refurbished
VITROS 5600 Integrated System
VITROS PHYT Slides
VITROS 5600 Integrated System Certified
VITROS UPRO Performance Verifiers
VITROS Calibrator Kit 10
VITROS UPRO Slides
VITROS A1c Slides
VITROS XT TRIG-CHOL Slides
VITROS Calibrator Kit 8
VITROS ALC Slides
VITROS DGXN Slides
VITROS ASTJ Slides
VITROS CHOL 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 LIPA Slides
VITROS GGT Slides
VITROS BuBc Slides
VITROS XT TBIL-ALKP Slides
VITROS TRIG Slides
VITROS Chemistry Products dHDL Slides
VITROS Chemistry Products Calibrator Kit 25
VITROS Chemistry Products Performance Verifiers
VITROS Ca Slides
VITROS Calibrator Kit 1
VITROS AMYL Slides
VITROS Mg Slides
VITROS AMON Slides
VITROS Calibrator Kit 5
VITROS THEO Slides
VITROS CRP Slides
VITROS Calibrator Kit 7
VITROS ALB-TP Slides
VITROS ECO2
VITROS Cl Slides
VITROS GLU Slides
VITROS ACET Slides
VITROS ALB Slides
VITROS Calibrator Kit 4
VITROS PROT SLides
VITROS TP Slides
VITROS K+ Slides
VITROS CHE Slides
VITROS PHBR Slides
VITROS Na+ Slides
VITROS ALT Slides
VITROS ALTV Slides
VITROS XT ALTV-AST Slides
VITROS CK Slides
VITROS Calibrator Kit 6
VITROS Isoenzyme PVs
VITROS CKMB Slides
VITROS dHDL Slides
VITROS Fe Slides
VITROS Chemistry Products ALBp Slides
VITROS URIC Slides
VITROS LDHI SLides
VITROS LDH Slides
VITROS BUN/UREA Slides
VITROS LAC Slides
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only