FDA Registration
Active
🇺🇸 United States
ORTHO-CLINICAL DIAGNOSTICS, INC.
Reg #: 1319808
·
FEI: 1000305841
·
Expires 2026
Products
53
Proprietary Names
116
Establishment Types
4
Classifications
53
Registration Details
- Registration Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Registration Number
- 1319808
- FEI Number
- 1000305841
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1000 LEE RD.
- City
- Rochester
- State
- NY
- ZIP
- 14606
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081543
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 |
|---|---|---|---|---|---|
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | 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 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2023-01-31 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2022-12-19 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzymatic Radiochemical Assay, Tobramycin | LDO | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2022-12-19 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2022-12-19 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2022-12-19 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| 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 | 2022-12-15 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2024-04-02 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2024-04-02 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2022-12-19 |
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2022-12-19 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2022-12-19 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Photometric Method, Ammonia | JID | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2022-12-19 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-12-19 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2022-12-19 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Alpha-1-Antitrypsin, Antigen, Antiserum, Control | DEM | Class 2 | Immunology | No | 2022-12-19 |
| Lowry (Colorimetric), Total Protein | JGP | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2022-12-19 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2022-12-19 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2022-12-19 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2023-02-17 |
| Method, Nephelometric, Immunoglobulins (G, A, M) | CFN | Class 2 | Immunology | No | 2022-12-19 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2023-02-27 |
Proprietary Names
VITROS Calibrator Kit 9
VITROS 5600 Integrated System Refurbished
VITROS 5600 Integrated System
VITROS PHYT Slides
VITROS 5600 Integrated System Certified
VITROS dLDL Reagent
VITROS Calibrator Kit 19
VITROS Performance Verifiers
VITROS Calibrator Kit 33
VITROS Calibrator Kit 14
VITROS TDM Performance Verifiers
VITROS TOBRA Reagent
VITROS ASO Reagent
VITROS ASO/RF Performance Verifiers
VITROS Calibrator Kit 28
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 11
VITROS VANC Reagent
VITROS Calibrator Kit 12
VITROS VALP Reagent
VITROS Immunodiagnostic Products hsTroponin I Calibrator
VITROS Calibrator Kit 25
VITROS Immunodiagnostic Products Progesterone 2 Calibrators
VITROS BENZ Reagent
VITROS TRFRN Reagent
VITROS Protein Performance Verifiers
VITROS Calibrator Kit 20
VITROS UDA Empty Packs
VITROS CRP Slides
VITROS Calibrator Kit 7
VITROS ALB Slides
VITROS Calibrator Kit 4
VITROS Chemistry Products dHDL Slides
VITROS Chemistry Products Calibrator Kit 25
VITROS Chemistry Products Performance Verifiers
VITROS Calibrator Kit 1
VITROS Mg Slides
VITROS AMPH Reagent
VITROS PALB Reagent
VITROS C3 Reagent
VITROS C4 Reagent
VITROS COCM Reagent
VITROS PALB Performance Verifiers
VITROS Calibrator Kit 23
VITROS AMON Slides
VITROS Calibrator Kit 5
VITROS Specialty Diluent
VITROS PCP Reagent
VITROS Calibrator Kit 27
VITROS Calibrator Kit 16
VITROS Immunodiagnostic Products CA 19-9 Calibrator
VITROS Ca Slides
VITROS Calibrator Kit 13
VITROS GENT Reagent
VITROS Percent A1c Performance Verifiers
VITROS HbA1c Reagent Kit
VITROS Calibrator Kit 31
VITROS CAFFN Reagent Kit
VITROS Calibrator Kit 24
VITROS mALB Performance Verifiers
VITROS mALB Reagent
VITROS Calibrator Kit 26
VITROS BARB Reagent
VITROS DAT Performance Verifiers
VITROS AAT Reagent
VITROS AAT/HPT Performance Verifiers
VITROS UPRO Performance Verifiers
VITROS Calibrator Kit 10
VITROS UPRO Slides
VITROS Calibrator Kit 17
VITROS RF Reagent
VITROS Calibrator Kit 8
VITROS ALC Slides
VITROS HPT Reagent
VITROS Liquid Performance Verifiers
VITROS Calibrator Kit 30
VITROS FS Calibrator 1
VITROS THC Reagent
VITROS OP Reagent
VITROS IgA Reagent
VITROS IgG Reagent
VITROS IgM Reagent
VITROS hsCRP Performance Verifiers
VITROS hsCRP Reagent
VITROS METD Reagent
VITROS ApoB Reagent
VITROS ApoA1 Reagent
VITROS Calibrator Kit 21
VITROS Calibrator Kit 22
VITROS ApoA1 Performance Verifiers
VITROS ApoB Performance Verifiers
VITROS CRP Performance Verifiers
VITROS dTIBC Performance Verifiers
VITROS Calibrator Kit 29
VITROS dTIBC Reagent
VITROS HCY2 Reagent
VITROS HCY2 Performance Verifiers
VITROS TIBC Kit
VITROS 4600 Chemistry System
VITROS 5,1 FS Chemistry System
VITROS 5,1 FS Chemistry System Refurbished
VITROS 4600 Chemistry System Refurbished
VITROS Calibrator Kit 99
VITROS Calibrator Kit 2
VITROS Calibrator Kit 32
VITROS Calibrator Kit 3
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198