FDA Registration
Active
🇬🇧 United Kingdom
Ortho-Clinical Diagnostics
Reg #: 3007111389
·
FEI: 3007111389
·
Expires 2026
Products
50
Proprietary Names
210
Establishment Types
2
Classifications
50
Registration Details
- Registration Name
- Ortho-Clinical Diagnostics
- Registration Number
- 3007111389
- FEI Number
- 3007111389
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Felindre Meadows
- City
- Pencoed Bridgend
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K231525
- PMA Number
- P090028
Owner / Operator
- Firm Name
- QuidelOrtho Corporation
- Operator Number
- 2024674
- Address
- 9975 Summers Ridge Road
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
US Agent
- Business Name
- Ortho-Clinical Diagnostics, Inc.
- Contact Name
- Raquel Almeida
- Address
- 1001 US Route 202
- City
- Raritan
- State
- NJ
- ZIP
- 08869
- Country
- US
- [email protected]
- Phone
- 908 7046825
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2024-04-02 |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | Class 2 | Microbiology | No | 2022-12-21 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2022-12-19 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2023-02-17 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2022-12-21 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2023-01-09 |
| Sars-Cov-2 Serology Test | QVP | Class 2 | Microbiology | No | 2023-08-21 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2023-01-09 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2023-01-09 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2025-05-14 |
| Qualitative And Quantitative Hepatitis B Virus Antibody Assays | SEI | Class 2 | Microbiology | No | 2023-01-09 |
| Kit, Serological, Positive Control | MJX | Class 1 | Clinical Chemistry | No | 2023-01-09 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2022-12-21 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2023-01-25 |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | Class 2 | Microbiology | No | 2023-01-09 |
| Kit, Test,Alpha-Fetoprotein For Testicular Cancer | LOJ | Class 2 | Immunology | No | 2022-12-21 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2023-07-11 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2022-12-21 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Kit, Serological, Negative Control | MJY | Class 1 | Clinical Chemistry | No | 2023-01-09 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2024-09-11 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2022-12-21 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2023-01-09 |
| Column Chromatography & Color Development, Hydroxyproline | JMM | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2022-12-21 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2023-01-09 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-11-24 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2022-12-21 |
Proprietary Names
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 Immunodiagnostic Products CA 19-9 Reagent Pack
VITROS Anti-HAV IgM Calibrator
VITROS Anti-HAV IgM Controls
VITROS Anti-HAV IgM Reagent Pack
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 27
VITROS Calibrator Kit 16
VITROS Immunodiagnostic Products CA 19-9 Calibrator
VITROS Total bhCG II Range Verifier
VITROS Total bhCG II Reagent Pack
VITROS Total bhCG II Calibrator
VITROS CEA Calibrators
VITROS CEA Reagent Pack
VITROS CEA Range Verifier
VITROS Anti-HBc IgM Controls
VITROS CA 19-9 Range Verifiers
VITROS CA 19-9 Calibrator
VITROS CA 19-9 Reagent Pack
VITROS FSH Calibrator
VITROS FSH Reagent Pack
VITROS HBeAg Calibrator
VITROS HBeAg Reagent Pack
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 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 25-OH Vitamin D Total Reagent Pack
VITROS 25-OH Vitamin D Total Calibrators
VITROS Total PSA Calibrator
VITROS Total PSA Reagent Pack
VITROS Testosterone Range Verifier
VITROS Testosterone Reagent Pack
VITROS Testosterone Calibrator
VITROS Total T3 II Reagent Pack
VITROS Total T3 II Calibrator
VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack
VITROS Anti-HAV Total Calibrators
VITROS Anti-HAV Total Controls
VITROS Anti-HAV Total 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 NTx Range Verifier
VITROS LH Reagent Pack
VITROS LH Calibrator
VITROS Free Thyroid Controls
VITROS Total Thyroid Controls
VITROS Testosterone Controls
VITROS RE Controls
VITROS Anemia Controls
VITROS Anti-HBs Quantitative Controls
VITROS NT pro-BNP Reagent Pack
VITROS NT pro-BNP Range Verifier
VITROS NT pro-BNP Calibrators
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 Troponin I ES Calibrators
VITROS Troponin I ES Reagent Pack
VITROS Troponin I ES Range Verifier
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 Immunodiagnostic Products Progesterone 2 Reagent Pack
VITROS NT-proBNP II Reagent Pack
VITROS Anti-HBc IgM Calibrator
VITROS Anti-HBc IgM Reagent Pack
VITROS HBsAg Controls
VITROS INTACT PTH Calibrators
VITROS INTACT PTH Reagent Pack
VITROS INTACT PTH Range Verifier
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
VITROS Immunodiagnostic Products hs Troponin I Calibrator
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
VITROS Total T4 Calibrator
VITROS Total T4 Reagent Pack
VITROS Anti-HBc Controls
VITROS Myoglobin Reagent Pack
VITROS Myoglobin Range Verifier
VITROS Myoglobin Calibrator
VITROS T3 Uptake II Calibrator
VITROS T3 Uptake II Reagent Pack
VITROS Immunodiagnostic Products hsTroponin I Calibrator
VITROS Calibrator Kit 25
VITROS Immunodiagnostic Products Progesterone 2 Calibrators
VITROS Anti-HCV Calibrators
VITROS Anti- HCV Reagent Pack
VITROS AFP Reagent Pack
VITROS AFP Calibrators
VITROS HIV Combo Calibrator
VITROS HIV Combo Reagent Pack
VITROS Rubella IgG Calibrator
VITROS Rubella IgG Reagent Pack
VITROS CK-MB Calibrator
VITROS CK-MB Reagent Pack
VITROS Anti-HCV Controls
VITROS Anti-HIV 1+2 Calibrator
VITROS Anti-HIV 1+2 Reagent Pack
VITROS B12/Folate Reagent Pack 1/2
VITROS B12 Calibrator
VITROS B12/Folate Reagent Pack 3
VITROS Insulin Calibrator
VITROS Insulin Reagent Pack
VITROS Immunodiagnostic Products Intact PTH II Calibrators
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
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 Ferritin Reagent Pack
VITROS Ferritin Calibrator
VITROS Anti-HBc Reagent Pack
VITROS Anti-HBc Calibrator
VITROS CA 15-3 Calibrator
VITROS CA 15-3 Reagent Pack
VITROS Anti-HBs Quantitative Reagent Pack
VITROS Anti-HBs Quantitative Calibrators
VITROS NTx Reagent Pack
VITROS NTx Controls
VITROS NTx Calibrator
VITROS Immunodiagnostic Products CEA Reagent Pack
VITROS Immunodiagnostic Products CEA Calibrators
VITROS T4 Calibrator
VITROS Free T4 Reagent Pack
VITROS BRAHMS PCT Range Verifier
VITROS BRAHMS PCT Calibrators
VITROS BRAHMS PCT Reagent Pack
VITROS BRAHMS PCT Controls
VITROS Anti-HBe Reagent Pack
VITROS Anti-HBe Calibrators
VITROS Red Cell Folate Pack
VITROS Folate Reagent Pack 1/2
VITROS Folate Calibrator
VITROS Prolactin Reagent Pack
VITROS Prolactin Calibrator
VITROS CA 125 II Calibrator
VITROS CA 125 II Reagent Pack
VITROS C-Peptide Calibrator
VITROS C-Peptide 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 Cortisol Calibrator
VITROS Cortisol Reagent Pack
VITROS Free T3 Calibrator
VITROS Free T3 Reagent Pack
VITROS HBsAg Confirmatory Kit
VITROS HBsAg Calibrator
VITROS HBsAg Reagent Pack
VITROS Progesterone Calibrator Kit
VITROS Progesterone Reagent Pack
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198