FDA Registration
Active
🇫🇷 France
Ortho-Clinical Diagnostics European Support Center
Reg #: 3000308930
·
FEI: 3000308930
·
Expires 2026
Products
112
Proprietary Names
325
Establishment Types
1
Classifications
112
Registration Details
- Registration Name
- Ortho-Clinical Diagnostics European Support Center
- Registration Number
- 3000308930
- FEI Number
- 3000308930
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1500 Boulevard Sebastien Brant, B.P. 30335
- City
- Illkirch, CEDEX Bas-Rhin
- Country
- FR
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 |
|---|---|---|---|---|---|
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2024-04-02 |
| System, Test, Automated Blood Grouping And Antibody | KSZ | Class 2 | Hematology | No | 2026-05-18 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2022-12-19 |
| Sars-Cov-2 Serology Test | QVP | Class 2 | Microbiology | No | 2023-05-23 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2023-01-09 |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | Class 1 | Immunology | No | 2022-12-09 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2024-09-11 |
| Kit, Quality Control For Blood Banking Reagents | KSF | Class 2 | Hematology | No | 2022-12-09 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Centrifuge, Cell-Washing, Automated For Immuno-Hematology | KSN | Class 2 | Hematology | No | 2022-12-09 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2023-01-09 |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2022-12-21 |
| Media, Potentiating For In Vitro Diagnostic Use | KSG | Class 2 | Hematology | No | 2022-12-09 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2022-12-19 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-11-24 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2023-01-11 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2023-01-09 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2022-12-19 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2023-02-27 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-12-19 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Method, Nephelometric, Immunoglobulins (G, A, M) | CFN | Class 2 | Immunology | No | 2022-12-19 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2022-12-15 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2022-12-19 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| 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 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2022-12-19 |
| Lectins And Protectins | KSI | Class 2 | Hematology | No | 2022-12-09 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2022-12-19 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| 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 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2022-12-21 |
| Flame Photometry, Lithium | JIH | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2024-06-28 |
| 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 |
| Qualitative And Quantitative Hepatitis B Virus Antibody Assays | SEI | Class 2 | Microbiology | No | 2023-01-09 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Photometric Method, Ammonia | JID | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2023-02-27 |
| Kit, Serological, Positive Control | MJX | Class 1 | Clinical Chemistry | No | 2023-01-09 |
| Kit, Serological, Negative Control | MJY | Class 1 | Clinical Chemistry | No | 2023-01-09 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2022-12-21 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2022-12-19 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2022-12-19 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2022-12-19 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2023-07-11 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | Class 2 | Microbiology | No | 2022-12-21 |
| Enzymatic Radiochemical Assay, Tobramycin | LDO | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Alpha-1-Antitrypsin, Antigen, Antiserum, Control | DEM | Class 2 | Immunology | No | 2022-12-19 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2022-12-21 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2025-03-25 |
| Starch-Dye Bound Polymer, Amylase | CIW | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2023-01-11 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Lowry (Colorimetric), Total Protein | JGP | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2024-06-03 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2023-01-25 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2023-01-09 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2023-01-09 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2022-12-19 |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | Class 2 | Microbiology | No | 2023-01-09 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2022-12-21 |
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 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 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
VITROS Percent A1c Performance Verifiers
VITROS HbA1c Reagent Kit
VITROS Calibrator Kit 31
VITROS COCM Reagent
VITROS SALI Slides
VITROS DGXN Slides
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-HBc IgM Calibrator
VITROS Anti-HBc IgM Reagent Pack
VITROS Anti-HAV Total Calibrators
VITROS Anti-HAV Total Controls
VITROS Anti-HAV Total Reagent Pack
ORTHO Confidence System
VITROS HIV Combo Calibrator
VITROS HIV Combo Reagent Pack
VITROS UPRO Performance Verifiers
VITROS Calibrator Kit 10
VITROS UPRO Slides
VITROS Calibrator Kit 11
VITROS VANC Reagent
VITROS FS Micro Tips
VITROS Versa Tips
VITROS Micro Tips
VITROS Testosterone Range Verifier
VITROS Testosterone Reagent Pack
VITROS Testosterone Calibrator
VITROS LDHI SLides
VITROS LDH Slides
VITROS CK-MB Range Verifier
VITROS Estradiol Range Verifier
VITROS Free T4 Range Verifier
VITROS Ferritin Range Verifier
VITROS Cortisol Calibrator
VITROS Cortisol Reagent Pack
VITROS URIC Slides
VITROS T3 Uptake II Calibrator
VITROS T3 Uptake II Reagent Pack
VITROS CA 15-3 Calibrator
VITROS CA 15-3 Reagent Pack
VITROS dLDL Reagent
VITROS Performance Verifiers
VITROS HCY2 Reagent
VITROS HCY2 Performance Verifiers
VITROS Free T3 Calibrator
VITROS Free T3 Reagent Pack
VITROS CA 19-9 Range Verifiers
VITROS CA 19-9 Calibrator
VITROS CA 19-9 Reagent Pack
VITROS 25-OH Vitamin D Total Reagent Pack
VITROS 25-OH Vitamin D Total Calibrators
VITROS NT pro-BNP Reagent Pack
VITROS NT pro-BNP Range Verifier
VITROS NT pro-BNP Calibrators
VITROS BuBc Slides
VITROS Estradiol Calibrator
VITROS Estradiol Reagent Pack
VITROS TRFRN Reagent
VITROS Protein Performance Verifiers
VITROS Calibrator Kit 20
VITROS Total bhCG II Range Verifier
VITROS Total bhCG II Reagent Pack
VITROS Total bhCG II Calibrator
VITROS Anti-HCV Calibrators
VITROS Anti- HCV Reagent Pack
ORTHO VISION Analyzer - Certified
ORTHO VISION Analyzer
ORTHO VISION Max Analyzer
VITROS T4 Calibrator
VITROS Free T4 Reagent Pack
VITROS Red Cell Folate Pack
VITROS Folate Reagent Pack 1/2
VITROS Folate Calibrator
Establishment Types
Complaint File Establishment per 21 CFR 820.198