FDA Registration
Active
🇺🇸 United States
ORTHO-CLINICAL DIAGNOSTICS, INC.
Reg #: 2250051
·
FEI: 2250051
·
Expires 2026
Products
124
Proprietary Names
354
Establishment Types
4
Classifications
124
Registration Details
- Registration Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Registration Number
- 2250051
- FEI Number
- 2250051
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1001 US Highway 202
- City
- RARITAN
- State
- NJ
- ZIP
- 08869
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041863
- PMA Number
- P030024
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 |
|---|---|---|---|---|---|
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2022-12-19 |
| Qualitative And Quantitative Hepatitis B Virus Antibody Assays | SEI | Class 2 | Microbiology | No | 2023-01-09 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2023-01-09 |
| Starch-Dye Bound Polymer, Amylase | CIW | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzyme Linked Immunosorbent Assay, T. Cruzi | MIU | Class 1 | Microbiology | No | 2022-12-09 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-12-19 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2023-07-11 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2024-06-03 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| 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 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2022-12-09 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2023-01-25 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2023-02-27 |
| System, Test, Automated Blood Grouping And Antibody | KSZ | Class 2 | Hematology | No | 2022-12-09 |
| Photometric Method, Ammonia | JID | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Media, Potentiating For In Vitro Diagnostic Use | KSG | Class 2 | Hematology | No | 2022-12-09 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2022-12-19 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2024-09-11 |
| 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 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2023-02-27 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2022-12-15 |
| 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 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2022-12-15 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Kit, Quality Control For Blood Banking Reagents | KSF | Class 2 | Hematology | No | 2025-12-08 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | Class 1 | Immunology | No | 2022-12-09 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2022-12-19 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzymatic Radiochemical Assay, Tobramycin | LDO | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2022-12-19 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2022-12-21 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2023-01-09 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2022-12-21 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Alpha-1-Antitrypsin, Antigen, Antiserum, Control | DEM | Class 2 | Immunology | No | 2022-12-19 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2025-03-25 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2023-12-14 |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2022-12-21 |
| Urease, Photometric, Urea Nitrogen | CDN | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Differential Rate Kinetic Method, Cpk Or Isoenzymes | JHS | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-11-24 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2023-01-11 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2023-01-09 |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2023-01-09 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2022-12-19 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Lectins And Protectins | KSI | Class 2 | Hematology | No | 2022-12-09 |
| Sars-Cov-2 Serology Test | QVP | Class 2 | Microbiology | No | 2023-05-23 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Test, Equipment, Automated Bloodborne Pathogen | MZA | Class N | Unknown | No | 2022-12-09 |
| Centrifuge, Cell-Washing, Automated For Immuno-Hematology | KSN | Class 2 | Hematology | No | 2022-12-09 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2023-01-09 |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | Class 2 | Microbiology | No | 2023-01-09 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2022-12-19 |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | Class 2 | Microbiology | No | 2022-12-21 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2023-01-09 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | 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 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2025-05-14 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Method, Nephelometric, Immunoglobulins (G, A, M) | CFN | Class 2 | Immunology | No | 2022-12-19 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2023-02-17 |
| Flame Photometry, Lithium | JIH | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2022-12-19 |
| 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 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Lowry (Colorimetric), Total Protein | JGP | Class 2 | Clinical Chemistry | No | 2022-12-19 |
Proprietary Names
VITROS Calibrator Kit 16
VITROS RF Reagent
VITROS Anti-HBc Reagent Pack
VITROS Anti-HBc Calibrator
VITROS AMYL Slides
VITROS AST Slides
VITROS LIPA 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 LDHI SLides
VITROS LDH Slides
VITROS CAFFN Reagent Kit
VITROS dTIBC Performance Verifiers
VITROS Calibrator Kit 29
VITROS dTIBC Reagent
VITROS Calibrator Kit 8
VITROS ALC Slides
ORTHO T.cruzi ELISA Test System
VITROS PCP Reagent
VITROS Anti-HIV 1+2 Calibrator
VITROS Anti-HIV 1+2 Reagent Pack
VITROS PALB Performance Verifiers
VITROS Calibrator Kit 23
VITROS HBeAg Calibrator
VITROS HBeAg Reagent Pack
VITROS TRIG Slides
VITROS Na+ Slides
VITROS SALI Slides
VITROS XT GLU-Ca Slides
VITROS BENZ Reagent
VITROS FS Micro Tips
VITROS Versa Tips
VITROS Micro Tips
VITROS Cortisol Calibrator
VITROS Cortisol Reagent Pack
VITROS ALB Slides
VITROS Calibrator Kit 4
VITROS Calibrator Kit 99
VITROS Calibrator Kit 2
VITROS Calibrator Kit 32
VITROS Calibrator Kit 3
ORTHO Bovine Serum Albumin, 22% Protein Concentration
ORTHO Bovine Albumin Solution Polymerized
VITROS Anti-HBs Quantitative Controls
VITROS T3 Uptake II Calibrator
VITROS T3 Uptake II Reagent Pack
VITROS 350 Chemistry System
VITROS 250 Chemistry System
VITROS 250 Chemistry System Refurbished
ORTHO Optix Reader
VITROS AMON Slides
VITROS Calibrator Kit 5
ORTHO Antibody Enhancement Solution
VITROS Calibrator Kit 12
VITROS VALP Reagent
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 K+ Slides
VITROS TRFRN Reagent
VITROS Protein Performance Verifiers
VITROS Calibrator Kit 20
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 C3 Reagent
VITROS C4 Reagent
VITROS ECiQ Immunodiagnostic System
VITROS ECi Immunodiagnostic System Refurbished
VITROS ECi Immunodiagnostic System
Ortho Optix Reader
VITROS Total T4 Calibrator
VITROS Total T4 Reagent Pack
VITROS dLDL Reagent
VITROS Calibrator Kit 19
VITROS Performance Verifiers
VITROS CHE Slides
VITROS Anti-HCV Controls
ORTHO VISION Analyzer - Certified
ORTHO VISION Analyzer
ORTHO VISION Max Analyzer
VITROS CRP Slides
VITROS Calibrator Kit 7
VITROS FSH Calibrator
VITROS FSH Reagent Pack
DAT Control, MTS DAT Card
VITROS CK-MB Calibrator
VITROS CK-MB Reagent Pack
VITROS Calibrator Kit 13
VITROS GENT Reagent
VITROS INTACT PTH Calibrators
VITROS INTACT PTH Reagent Pack
VITROS INTACT PTH Range Verifier
Ortho Rhhr Control (human & bovine)
VITROS Anti-HBe Reagent Pack
VITROS Anti-HBe Calibrators
VITROS ASO Reagent
VITROS ASO/RF Performance Verifiers
VITROS Calibrator Kit 28
VITROS Calibrator Kit 9
VITROS 5600 Integrated System Refurbished
VITROS 5600 Integrated System
VITROS PHYT Slides
VITROS 5600 Integrated System Certified
VITROS Calibrator Kit 14
VITROS TDM Performance Verifiers
VITROS TOBRA Reagent
VITROS PALB Reagent
VITROS Myoglobin Reagent Pack
VITROS Myoglobin Range Verifier
VITROS Myoglobin Calibrator
VITROS 25-OH Vitamin D Total Reagent Pack
VITROS 25-OH Vitamin D Total Calibrators
VITROS Calibrator Kit 30
VITROS FS Calibrator 1
VITROS THC Reagent
VITROS Calibrator Kit 1
VITROS Mg 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 PROT SLides
VITROS TP Slides
VITROS dHDL Slides
MTS Diluent 2
VITROS AAT Reagent
VITROS AAT/HPT Performance Verifiers
VITROS AMPH Reagent
VITROS NT-proBNP II Reagent Pack
VITROS Testosterone Range Verifier
VITROS Testosterone Reagent Pack
VITROS Testosterone Calibrator
VITROS Troponin I ES Calibrators
VITROS Troponin I ES Reagent Pack
VITROS Troponin I ES Range Verifier
VITROS Immunodiagnostic Products CEA Reagent Pack
VITROS Immunodiagnostic Products CEA Calibrators
VITROS HIV Combo Calibrator
VITROS HIV Combo Reagent Pack
VITROS BRAHMS PCT Range Verifier
VITROS BRAHMS PCT Calibrators
VITROS BRAHMS PCT Reagent Pack
VITROS BRAHMS PCT Controls
VITROS Anti-HBc Controls
VITROS Immunodiagnostic Products Intact PTH II Calibrators
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
VITROS Chemistry Products dHDL Slides
VITROS Chemistry Products Calibrator Kit 25
VITROS Chemistry Products Performance Verifiers
VITROS BUN/UREA Slides
VITROS Total bhCG II Range Verifier
VITROS Total bhCG II Reagent Pack
VITROS Total bhCG II Calibrator
VITROS Red Cell Folate Pack
VITROS Folate Reagent Pack 1/2
VITROS Folate Calibrator
VITROS CK Slides
VITROS Calibrator Kit 6
VITROS Isoenzyme PVs
VITROS CKMB Slides
VITROS URIC Slides
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 Liquid Performance Verifiers
VITROS DGXN Slides
VITROS Calibrator Kit 26
VITROS BARB Reagent
VITROS DAT Performance Verifiers
VITROS Total PSA Calibrator
VITROS Total PSA Reagent Pack
VITROS CA 19-9 Range Verifiers
VITROS CA 19-9 Calibrator
VITROS CA 19-9 Reagent Pack
VITROS Anti-HBc IgM Calibrator
VITROS Anti-HBc IgM Reagent Pack
VITROS TIBC Kit
VITROS Calibrator Kit 17
VITROS BuBc Slides
VITROS Prolactin Reagent Pack
VITROS Prolactin Calibrator
VITROS Calibrator Kit 27
VITROS Immunodiagnostic Products CA 19-9 Calibrator
Ortho Anti A1 Lectin
VITROS NTx Range Verifier
VITROS Immunodiagnostic Products CA 19-9 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 Fe Slides
VITROS ACET Slides
VITROS Ca Slides
ORTHO Confidence System
VITROS Anti-HBs Quantitative Reagent Pack
VITROS Anti-HBs Quantitative Calibrators
VITROS Calibrator Kit 11
VITROS VANC Reagent
ORTHO VERSEIA Pipettor (VERSEIA)
ORTHO Summit Processor (OSP)
ORTHO VERSEIA Integrated Processor (VIP)
ORTHO Workstation
VITROS NT pro-BNP Reagent Pack
VITROS NT pro-BNP Range Verifier
VITROS NT pro-BNP Calibrators
VITROS HBsAg Controls
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 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 T4 Calibrator
VITROS Free T4 Reagent Pack
VITROS CA 15-3 Calibrator
VITROS CA 15-3 Reagent Pack
VITROS Anti-HCV Calibrators
VITROS Anti- HCV Reagent Pack
VITROS Calibrator Kit 24
VITROS mALB Performance Verifiers
VITROS mALB Reagent
VITROS LAC Slides
MTS Diluent 2 PLUS
VITROS XT TRIG-CHOL Slides
VITROS OP Reagent
VITROS CHOL 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 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 Anti-HAV Total Calibrators
VITROS Anti-HAV Total Controls
VITROS Anti-HAV Total Reagent Pack
VITROS hsCRP Performance Verifiers
VITROS hsCRP Reagent
VITROS CA 125 II Calibrator
VITROS CA 125 II Reagent Pack
VITROS METD Reagent
VITROS XT TBIL-ALKP Slides
VITROS CEA Calibrators
VITROS CEA Reagent Pack
VITROS CEA Range Verifier
VITROS GGT Slides
VITROS ALB-TP Slides
VITROS ECO2
VITROS Cl Slides
VITROS GLU Slides
VITROS 4600 Chemistry System
VITROS 5,1 FS Chemistry System
VITROS 5,1 FS Chemistry System Refurbished
VITROS 4600 Chemistry System Refurbished
VITROS Anti-HBc IgM Controls
VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack
VITROS ApoB Reagent
VITROS ApoA1 Reagent
VITROS Calibrator Kit 21
VITROS Calibrator Kit 22
VITROS ApoA1 Performance Verifiers
VITROS ApoB Performance Verifiers
VITROS Immunodiagnostic Products hsTroponin I Calibrator
VITROS Calibrator Kit 25
VITROS Immunodiagnostic Products Progesterone 2 Calibrators
VITROS ALT Slides
VITROS ALTV Slides
VITROS XT ALTV-AST Slides
VITROS IgA Reagent
VITROS IgG Reagent
VITROS IgM Reagent
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 HBsAg Confirmatory Kit
VITROS HBsAg Calibrator
VITROS HBsAg Reagent Pack
VITROS Li Slides
VITROS Free T3 Calibrator
VITROS Free T3 Reagent Pack
VITROS Total T3 II Reagent Pack
VITROS Total T3 II Calibrator
VITROS Anti-HAV IgM Calibrator
VITROS Anti-HAV IgM Controls
VITROS Anti-HAV IgM Reagent Pack
Ortho Coombs Control
VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack
VITROS HPT Reagent
VITROS Percent A1c Performance Verifiers
VITROS HbA1c Reagent Kit
VITROS Calibrator Kit 31
VITROS COCM Reagent
VITROS HCY2 Reagent
VITROS HCY2 Performance Verifiers
VITROS Progesterone Calibrator Kit
VITROS Progesterone Reagent Pack
VITROS UPRO Performance Verifiers
VITROS Calibrator Kit 10
VITROS UPRO Slides
VITROS THEO Slides
VITROS CRP Performance Verifiers
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)