FDA Registration
Active
🇺🇸 United States
ORTHO-CLINICAL DIAGNOSTICS, INC.
Reg #: 1319681
·
FEI: 1000136573
·
Expires 2026
Products
137
Proprietary Names
391
Establishment Types
4
Classifications
137
Registration Details
- Registration Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Registration Number
- 1319681
- FEI Number
- 1000136573
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 Indigo Creek Dr
- City
- Rochester
- State
- NY
- ZIP
- 14626
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152433
- PMA Number
- P100001
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 |
|---|---|---|---|---|---|
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2022-12-15 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2022-12-15 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2023-01-09 |
| Qualitative And Quantitative Hepatitis B Virus Antibody Assays | SEI | Class 2 | Microbiology | No | 2023-01-09 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2022-12-19 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2024-06-03 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | Class 2 | Microbiology | No | 2022-12-21 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Interleukin 6 | QLC | Class N | Unknown | No | 2025-05-12 |
| Drug Mixture Control Materials | DIF | Class 1 | 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 |
| Photometric Method, Ammonia | JID | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Alpha-1-Antitrypsin, Antigen, Antiserum, Control | DEM | Class 2 | Immunology | No | 2022-12-19 |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | Class 1 | Immunology | No | 2022-12-09 |
| Media, Potentiating For In Vitro Diagnostic Use | KSG | Class 2 | Hematology | No | 2022-12-09 |
| Test, Equipment, Automated Bloodborne Pathogen | MZA | Class N | Unknown | No | 2022-12-09 |
| Kit, Quality Control For Blood Banking Reagents | KSF | Class 2 | Hematology | No | 2022-12-09 |
| 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 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| 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 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2022-12-19 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Kit, Serological, Positive Control | MJX | Class 1 | Clinical Chemistry | No | 2023-01-09 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2023-01-09 |
| 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 |
| Kit, Test,Alpha-Fetoprotein For Testicular Cancer | LOJ | Class 2 | Immunology | No | 2022-12-21 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2023-01-11 |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2024-04-02 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2022-12-09 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2022-12-21 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Differential Rate Kinetic Method, Cpk Or Isoenzymes | JHS | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2025-11-26 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2023-01-25 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2023-07-11 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Lowry (Colorimetric), Total Protein | JGP | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2023-01-09 |
| Sars-Cov-2 Serology Test | QVP | Class 2 | Microbiology | No | 2023-05-23 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2022-12-19 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2022-12-21 |
| Method, Nephelometric, Immunoglobulins (G, A, M) | CFN | Class 2 | Immunology | No | 2022-12-19 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2023-02-27 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2022-12-19 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2022-12-19 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| 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 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| 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, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| System, Test, Automated Blood Grouping And Antibody | KSZ | Class 2 | Hematology | No | 2025-12-11 |
| Starch-Dye Bound Polymer, Amylase | CIW | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2022-12-19 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2022-12-19 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2022-12-21 |
| Urease, Photometric, Urea Nitrogen | CDN | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2023-01-11 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2024-09-11 |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | Class 2 | Microbiology | No | 2023-01-09 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Radioassay, Vitamin B12 | CDD | 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 |
| Enzyme Linked Immunosorbent Assay, T. Cruzi | MIU | Class 1 | Microbiology | No | 2022-12-09 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2022-12-21 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Centrifuge, Cell-Washing, Automated For Immuno-Hematology | KSN | Class 2 | Hematology | No | 2022-12-09 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2023-01-11 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-12-19 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2022-12-21 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2023-01-11 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2022-12-19 |
| Kit, Serological, Negative Control | MJY | Class 1 | Clinical Chemistry | No | 2023-01-09 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-11-24 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2023-02-17 |
| Lectins And Protectins | KSI | Class 2 | Hematology | No | 2022-12-09 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2023-01-09 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2024-09-06 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2022-12-21 |
| Flame Photometry, Lithium | JIH | Class 2 | Clinical Toxicology | No | 2022-12-15 |
| 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 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2025-05-14 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2022-12-19 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2023-01-09 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2022-12-19 |
| Column Chromatography & Color Development, Hydroxyproline | JMM | Class 1 | Clinical Chemistry | No | 2022-12-21 |
Proprietary Names
VITROS CRP Slides
VITROS Calibrator Kit 7
VITROS CHE Slides
VITROS Anti-HBe Reagent Pack
VITROS Anti-HBe Calibrators
VITROS Specialty Diluent
VITROS PROT SLides
VITROS TP Slides
VITROS FS Micro Tips
VITROS Versa Tips
VITROS Micro Tips
VITROS Calibrator Kit 4
VITROS TIBC Kit
VITROS Anti-HAV IgM Calibrator
VITROS Anti-HAV IgM Controls
VITROS Anti-HAV IgM Reagent Pack
VITROS INTACT PTH Calibrators
VITROS INTACT PTH Reagent Pack
VITROS INTACT PTH Range Verifier
VITROS LH Reagent Pack
VITROS LH Calibrator
VITROS HBsAg Confirmatory Kit
VITROS HBsAg Calibrator
VITROS HBsAg Reagent Pack
VITROS CHOL Slides
VITROS Immunodiagnostic Products IL-6 Reagent Pack
VITROS Immunodiagnostic Products IL-6 Calibrator
VITROS Immunodiagnostic Products IL-6 Controls
VITROS BENZ Reagent
VITROS AMON Slides
VITROS Calibrator Kit 5
VITROS AAT Reagent
VITROS AAT/HPT Performance Verifiers
Ortho Rhhr Control (human & bovine)
MTS Diluent 2
ORTHO VERSEIA Pipettor (VERSEIA)
ORTHO Summit Processor (OSP)
ORTHO VERSEIA Integrated Processor (VIP)
ORTHO Confidence System
VITROS Calibrator Kit 9
VITROS 5600 Integrated System Refurbished
VITROS 5600 Integrated System
VITROS PHYT Slides
VITROS 5600 Integrated System Certified
VITROS Cortisol Calibrator
VITROS Cortisol Reagent Pack
VITROS Free Thyroid Controls
VITROS Total Thyroid Controls
VITROS Testosterone Controls
VITROS RE Controls
VITROS Anemia Controls
VITROS Calibrator Kit 14
VITROS TDM Performance Verifiers
VITROS TOBRA Reagent
VITROS dLDL Reagent
VITROS Calibrator Kit 19
VITROS Performance Verifiers
VITROS 4600 Chemistry System
VITROS 5,1 FS Chemistry System
VITROS 5,1 FS Chemistry System Refurbished
VITROS 4600 Chemistry System Refurbished
MTS Diluent 2 PLUS
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 Anti-HAV Total Calibrators
VITROS Anti-HAV Total Controls
VITROS Anti-HAV Total Reagent Pack
VITROS Total T4 Calibrator
VITROS Total T4 Reagent Pack
VITROS NT pro-BNP Reagent Pack
VITROS NT pro-BNP Range Verifier
VITROS NT pro-BNP Calibrators
VITROS HBsAg Controls
VITROS PHOS Slides
VITROS Total PSA Calibrator
VITROS Total PSA Reagent Pack
VITROS XT TBIL-ALKP Slides
VITROS AFP Reagent Pack
VITROS AFP 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 DGXN Slides
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
VITROS K+ Slides
VITROS Liquid Performance Verifiers
VITROS AMPH Reagent
VITROS Calibrator Kit 8
VITROS ALC Slides
ORTHO Bovine Serum Albumin, 22% Protein Concentration
ORTHO Bovine Albumin Solution Polymerized
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 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 BuBc Slides
VITROS CK Slides
VITROS Calibrator Kit 6
VITROS Isoenzyme PVs
VITROS CKMB Slides
VITROS Immunodiagnostic Products hs Troponin I Low Control
VITROS Immunodiagnostic Products hs Troponin I Calibrator
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
VITROS Calibrator Kit 13
VITROS GENT Reagent
VITROS Calibrator Kit 27
VITROS Calibrator Kit 16
VITROS Immunodiagnostic Products CA 19-9 Calibrator
VITROS T3 Uptake II Calibrator
VITROS T3 Uptake II Reagent Pack
VITROS CAFFN Reagent Kit
VITROS Ca Slides
VITROS Calibrator Kit 1
VITROS LIPA Slides
VITROS UDA Empty Packs
VITROS Anti-HIV 1+2 Calibrator
VITROS Anti-HIV 1+2 Reagent Pack
VITROS Free T3 Calibrator
VITROS Free T3 Reagent Pack
VITROS METD Reagent
VITROS UPRO Performance Verifiers
VITROS Calibrator Kit 10
VITROS UPRO Slides
VITROS Anti-HBc Controls
VITROS 25-OH Vitamin D Total Reagent Pack
VITROS 25-OH Vitamin D Total Calibrators
VITROS Anti-SARS-CoV-2 IgG Calibrator
VITROS Anti-SARS-CoV-2 IgG Reagent Pack
VITROS Anti-SARS-CoV-2 IgG Controls
VITROS ACET Slides
VITROS ApoB Reagent
VITROS ApoA1 Reagent
VITROS Calibrator Kit 21
VITROS Calibrator Kit 22
VITROS ApoA1 Performance Verifiers
VITROS ApoB Performance Verifiers
VITROS GGT Slides
VITROS Myoglobin Reagent Pack
VITROS Myoglobin Range Verifier
VITROS Myoglobin Calibrator
VITROS Anti-HBc IgM Calibrator
VITROS Anti-HBc IgM Reagent Pack
VITROS PALB Performance Verifiers
VITROS Calibrator Kit 23
VITROS CRP Performance Verifiers
VITROS dTIBC Performance Verifiers
VITROS Calibrator Kit 29
VITROS dTIBC Reagent
VITROS IgA Reagent
VITROS IgG Reagent
VITROS IgM Reagent
VITROS Anti-HBs Quantitative Controls
VITROS T4 Calibrator
VITROS Free T4 Reagent Pack
VITROS Red Cell Folate Pack
VITROS Folate Reagent Pack 1/2
VITROS Folate Calibrator
VITROS ECiQ Immunodiagnostic System
VITROS ECi Immunodiagnostic System Refurbished
VITROS ECi Immunodiagnostic System
VITROS Percent A1c Performance Verifiers
VITROS HbA1c Reagent Kit
VITROS Calibrator Kit 31
VITROS PALB Reagent
VITROS ALT Slides
VITROS ALTV Slides
VITROS XT ALTV-AST Slides
VITROS ASO Reagent
VITROS ASO/RF Performance Verifiers
VITROS Calibrator Kit 28
VITROS FSH Calibrator
VITROS FSH Reagent Pack
VITROS Anti-HBc Reagent Pack
VITROS Anti-HBc Calibrator
VITROS XT TRIG-CHOL Slides
VITROS ECO2
VITROS Cl Slides
VITROS GLU Slides
VITROS Estradiol Calibrator
VITROS Estradiol Reagent Pack
ORTHO VISION Analyzer - Certified
ORTHO VISION Analyzer
ORTHO VISION Max Analyzer
VITROS AMYL Slides
VITROS Calibrator Kit 17
VITROS Anti-HBc IgM Controls
VITROS Progesterone Calibrator Kit
VITROS Progesterone Reagent Pack
VITROS TRFRN Reagent
VITROS Protein Performance Verifiers
VITROS Calibrator Kit 20
VITROS Total T3 II Reagent Pack
VITROS Total T3 II Calibrator
VITROS XT GLU-Ca Slides
VITROS Ferritin Reagent Pack
VITROS Ferritin Calibrator
VITROS CK-MB Range Verifier
VITROS Estradiol Range Verifier
VITROS Free T4 Range Verifier
VITROS Ferritin Range Verifier
VITROS BUN/UREA Slides
VITROS PHBR Slides
VITROS dHDL Slides
Ortho Optix Reader
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 Calibrator Kit 11
VITROS VANC Reagent
VITROS HCY2 Reagent
VITROS HCY2 Performance Verifiers
Ortho Coombs Control
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 Anti-HCV Calibrators
VITROS Anti- HCV Reagent Pack
VITROS Total bhCG II Range Verifier
VITROS Total bhCG II Reagent Pack
VITROS Total bhCG II Calibrator
VITROS LAC Slides
VITROS HIV Combo Calibrator
VITROS HIV Combo Reagent Pack
VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack
VITROS B12/Folate Reagent Pack 1/2
VITROS B12 Calibrator
VITROS B12/Folate Reagent Pack 3
VITROS BRAHMS PCT Range Verifier
VITROS BRAHMS PCT Calibrators
VITROS BRAHMS PCT Reagent Pack
VITROS BRAHMS PCT Controls
VITROS THEO Slides
VITROS CA 19-9 Range Verifiers
VITROS CA 19-9 Calibrator
VITROS CA 19-9 Reagent Pack
ORTHO T.cruzi ELISA Test System
ORTHO Antibody Enhancement Solution
VITROS Insulin Calibrator
VITROS Insulin Reagent Pack
VITROS CEA Calibrators
VITROS CEA Reagent Pack
VITROS CEA Range Verifier
VITROS ALKP Slides
VITROS Calibrator Kit 26
VITROS BARB Reagent
VITROS DAT Performance Verifiers
VITROS ALB-TP Slides
ORTHO Workstation
VITROS COCM Reagent
VITROS Na+ Slides
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 Mg Slides
VITROS TRIG Slides
VITROS Calibrator Kit 99
VITROS Calibrator Kit 2
VITROS Calibrator Kit 32
VITROS Calibrator Kit 3
VITROS Calibrator Kit 24
VITROS mALB Performance Verifiers
VITROS mALB Reagent
VITROS SALI Slides
VITROS Immunodiagnostic Products Intact PTH II Calibrators
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
VITROS OP Reagent
VITROS NT-proBNP II Reagent Pack
VITROS Prolactin Reagent Pack
VITROS Prolactin Calibrator
VITROS AST Slides
VITROS PCP Reagent
VITROS HBeAg Calibrator
VITROS HBeAg Reagent Pack
VITROS 350 Chemistry System
VITROS 250 Chemistry System
VITROS 250 Chemistry System Refurbished
VITROS Anti-HBs Quantitative Reagent Pack
VITROS Anti-HBs Quantitative Calibrators
ORTHO Optix Reader
VITROS Immunodiagnostic Products CEA Reagent Pack
VITROS Immunodiagnostic Products CEA Calibrators
VITROS hsCRP Performance Verifiers
VITROS hsCRP Reagent
VITROS ALB Slides
VITROS CK-MB Calibrator
VITROS CK-MB Reagent Pack
VITROS URIC Slides
VITROS RF Reagent
VITROS Anti-HCV Controls
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 NTx Range Verifier
VITROS Troponin I ES Calibrators
VITROS Troponin I ES Reagent Pack
VITROS Troponin I ES Range Verifier
VITROS XT UREA-CREA Slides
Ortho Anti A1 Lectin
VITROS CA 15-3 Calibrator
VITROS CA 15-3 Reagent Pack
VITROS Testosterone Range Verifier
VITROS Testosterone Reagent Pack
VITROS Testosterone Calibrator
VITROS Immunodiagnostic Products Syphilis Reagent Pack
VITROS Immunodiagnostic Products Syphilis Calibrator
VITROS Immunodiagnostic Products Syphilis Controls
VITROS Rubella IgG Calibrator
VITROS Rubella IgG Reagent Pack
VITROS Li Slides
VITROS C3 Reagent
VITROS C4 Reagent
VITROS Chemistry Products dHDL Slides
VITROS Chemistry Products Calibrator Kit 25
VITROS Chemistry Products Performance Verifiers
VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack
DAT Control, MTS DAT Card
VITROS HPT Reagent
VITROS Fe Slides
VITROS Calibrator Kit 12
VITROS VALP Reagent
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 hsTroponin I Calibrator
VITROS Calibrator Kit 25
VITROS Immunodiagnostic Products Progesterone 2 Calibrators
VITROS C-Peptide Calibrator
VITROS C-Peptide Reagent Pack
VITROS LDHI SLides
VITROS LDH Slides
VITROS CA 125 II Calibrator
VITROS CA 125 II Reagent Pack
VITROS Calibrator Kit 30
VITROS FS Calibrator 1
VITROS THC Reagent
VITROS NTx Reagent Pack
VITROS NTx Controls
VITROS NTx Calibrator
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only
Manufacture Medical Device