ORTHO-CLINICAL DIAGNOSTICS, INC.

FDA Device Registration & Listing · ROCHESTER, NY, US · Registration 1319809

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1319809
FEI Number
1000305840
Entity Name
ORTHO-CLINICAL DIAGNOSTICS, INC.
City/State/Country
ROCHESTER, NY, US
Establishment Address
513 Technology Blvd., ROCHESTER, NY 14626, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
QuidelOrtho Corporation (Owner Number: 2024674)
Owner / Operator Contact Address
9975 Summers Ridge Road, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K081411
PMA Number
N/A

All Registered Proprietary Names

VITROS ALKP Slides VITROS XT UREA-CREA Slides VITROS ALT2 Slides VITYROS XT ALT2-ASTJ Slides VITROS XT GLU-Ca Slides VITROS Li Slides VITROS PHOS Slides VITROS AST Slides VITROS SALI Slides VITROS Calibrator Kit 9 VITROS 5600 Integrated System Refurbished VITROS 5600 Integrated System VITROS PHYT Slides VITROS 5600 Integrated System Certified VITROS UPRO Performance Verifiers VITROS Calibrator Kit 10 VITROS UPRO Slides VITROS A1c Slides VITROS XT TRIG-CHOL Slides VITROS Calibrator Kit 8 VITROS ALC Slides VITROS DGXN Slides VITROS ASTJ Slides VITROS CHOL 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 LIPA Slides VITROS GGT Slides VITROS BuBc Slides VITROS XT TBIL-ALKP Slides VITROS TRIG Slides VITROS Chemistry Products dHDL Slides VITROS Chemistry Products Calibrator Kit 25 VITROS Chemistry Products Performance Verifiers VITROS Ca Slides VITROS Calibrator Kit 1 VITROS AMYL Slides VITROS Calibrator Kit 1 VITROS Mg Slides VITROS AMON Slides VITROS Calibrator Kit 5 VITROS THEO Slides VITROS CRP Slides VITROS Calibrator Kit 7 VITROS ALB-TP Slides VITROS ECO2 VITROS Cl Slides VITROS GLU Slides VITROS ACET Slides VITROS ALB Slides VITROS Calibrator Kit 4 VITROS PROT SLides VITROS TP Slides VITROS K+ Slides VITROS CHE Slides VITROS PHBR Slides VITROS Na+ Slides

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2022-12-15
CDN Urease, Photometric, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2023-01-11
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2023-01-11
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2023-01-31
CJY Azo Dye, Calcium Clinical Chemistry Class 2 862.1145 2023-01-11
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2023-01-11
JIH Flame Photometry, Lithium Clinical Toxicology Class 2 862.3560 2022-12-15
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2022-12-15
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2022-12-15
DKJ Colorimetry, Salicylate Clinical Toxicology Class 2 862.3830 2022-12-15
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2022-12-19
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-19
DIP Enzyme Immunoassay, Diphenylhydantoin Clinical Toxicology Class 2 862.3350 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-19
JGP Lowry (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2022-12-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2022-12-19
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2023-01-31
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2023-01-11
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2023-01-11
DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet Clinical Toxicology Class 2 862.3040 2022-12-19
LFM Enzyme Immunoassay, Digitoxin Clinical Toxicology Class 2 862.3300 2023-01-11
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2023-01-31
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2022-12-15
KLT Enzyme Immunoassay, Carbamazepine Clinical Toxicology Class 2 862.3645 2022-12-21
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2022-12-21
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2022-12-21
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2022-12-21
CHI Lipase-Esterase, Enzymatic, Photometric, Lipase Clinical Chemistry Class 1 862.1465 2022-12-15
JQB Kinetic Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 2023-01-11
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2022-12-15
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2023-01-11
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2023-01-11
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2022-12-15
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2024-04-02
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-04-02
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2024-04-02
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2022-12-15
CJY Azo Dye, Calcium Clinical Chemistry Class 2 862.1145 2022-12-15
CIW Starch-Dye Bound Polymer, Amylase Clinical Chemistry Class 2 862.1070 2022-12-15
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2022-12-15
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2022-12-15
JID Photometric Method, Ammonia Clinical Chemistry Class 1 862.1065 2022-12-15
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2022-12-15
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2022-12-15
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-15
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2023-01-11
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2022-12-15
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2022-12-15
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2022-12-15
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2022-12-15
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2022-12-15
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2022-12-15
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2023-01-11
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2023-01-11
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2023-01-11
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2022-12-15
DLZ Enzyme Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2023-01-11
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-01-11
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2023-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QuidelOrtho Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1056600 MICRO TYPING SYSTEMS, INC. POMPANO BEACH, FL, US
3002642396 Ortho Clinical Diagnostics Singapore South West, SG
2250051 ORTHO-CLINICAL DIAGNOSTICS, INC. RARITAN, NJ, US
1528450 Ortho-Clinical Diagnostics, Inc. ATHENS, OH, US
2024674 QUIDEL CORP. SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K872302 Ciba Corning Diagnostics Corp. MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER 1987-09-08
K771442 Instrumentation Laboratory CO MULTISTAT III UREA NITROGEN TEST 1977-08-22
K012065 Wiener Laboratories Saic WIENER LAB. CREATININA CINETICA AA 2001-10-10
K183555 Instrumentation Laboratory CO GEM Premier ChemSTAT 2019-02-16
K090330 Siemens Healthcare Diagnostics, Inc. DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 2009-05-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2015 Ortho-Clinical Diagnostics 2
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Z-0008-06 Abbott Laboratories, Inc 1
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024 Ortho-Clinical Diagnostics, Inc. 1
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06 Beckman Coulter Inc 1
Synchron LX Systems Version 4.5 Operating Software
Z-0010-06 Abbott Laboratories, Inc 1
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

Similar Registrations

Registration Number Establishment Name Location
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3000308930 Ortho-Clinical Diagnostics European Support Center Illkirch, CEDEX Bas-Rhin, FR
3003795116 ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROTKREUZ Zug, CH
9610126 ROCHE DIAGNOSTICS GMBH MANNHEIM Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319809. Last updated year: 2026. Please use registration number 1319809 when referencing this establishment in official correspondence.
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