ORTHO-CLINICAL DIAGNOSTICS, INC.

FDA Device Registration & Listing · Rochester, NY, US · Registration 1319808

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
1319808
FEI Number
1000305841
Entity Name
ORTHO-CLINICAL DIAGNOSTICS, INC.
City/State/Country
Rochester, NY, US
Establishment Address
1000 LEE RD., Rochester, NY 14606, US
Establishment Type(s)
Repack or Relabel Medical Device,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
N/A
PMA Number
N/A

All Registered Proprietary Names

VITROS Calibrator Kit 9 VITROS 5600 Integrated System Refurbished VITROS 5600 Integrated System VITROS PHYT Slides VITROS 5600 Integrated System Certified VITROS dLDL Reagent VITROS Calibrator Kit 19 VITROS Performance Verifiers VITROS Calibrator Kit 33 VITROS Calibrator Kit 14 VITROS TDM Performance Verifiers VITROS TOBRA Reagent VITROS ASO Reagent VITROS ASO/RF Performance Verifiers VITROS Calibrator Kit 28 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 11 VITROS VANC Reagent VITROS Calibrator Kit 12 VITROS VALP Reagent VITROS Immunodiagnostic Products hsTroponin I Calibrator VITROS Calibrator Kit 25 VITROS Immunodiagnostic Products Progesterone 2 Calibrators VITROS BENZ Reagent VITROS TRFRN Reagent VITROS Protein Performance Verifiers VITROS Calibrator Kit 20 VITROS UDA Empty Packs VITROS CRP Slides VITROS Calibrator Kit 7 VITROS ALB Slides VITROS Calibrator Kit 4 VITROS Chemistry Products dHDL Slides VITROS Chemistry Products Calibrator Kit 25 VITROS Chemistry Products Performance Verifiers VITROS Calibrator Kit 1 VITROS Mg Slides VITROS AMPH Reagent VITROS PALB Reagent VITROS C3 Reagent VITROS C4 Reagent VITROS COCM Reagent VITROS PALB Performance Verifiers VITROS Calibrator Kit 23 VITROS AMON Slides VITROS Calibrator Kit 5 VITROS Specialty Diluent VITROS PCP Reagent VITROS Calibrator Kit 27 VITROS Calibrator Kit 16 VITROS Immunodiagnostic Products CA 19-9 Calibrator VITROS Ca Slides VITROS Calibrator Kit 1 VITROS Calibrator Kit 13 VITROS GENT Reagent VITROS Percent A1c Performance Verifiers VITROS HbA1c Reagent Kit VITROS Calibrator Kit 31 VITROS CAFFN Reagent Kit VITROS Calibrator Kit 24 VITROS mALB Performance Verifiers VITROS mALB Reagent VITROS Calibrator Kit 26 VITROS BARB Reagent VITROS DAT Performance Verifiers VITROS AAT Reagent VITROS AAT/HPT Performance Verifiers VITROS UPRO Performance Verifiers VITROS Calibrator Kit 10 VITROS UPRO Slides VITROS Calibrator Kit 17 VITROS Calibrator Kit 16 VITROS RF Reagent VITROS Calibrator Kit 8 VITROS ALC Slides VITROS HPT Reagent

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-19
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2022-12-19
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2023-01-31
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2022-12-19
LDO Enzymatic Radiochemical Assay, Tobramycin Clinical Toxicology Class 2 862.3900 2022-12-19
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 2022-12-19
PPM General Purpose Reagent Pathology Class 1 864.4010 2022-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2022-12-19
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2022-12-19
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2022-12-19
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2022-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2022-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2022-12-19
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2022-12-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-19
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-19
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2022-12-19
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 2022-12-15
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 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
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
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2022-12-19
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2022-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
JZJ Prealbumin, Antigen, Antiserum, Control Immunology Class 1 866.5060 2022-12-19
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2022-12-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-19
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2022-12-19
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2022-12-19
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2022-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-19
JID Photometric Method, Ammonia Clinical Chemistry Class 1 862.1065 2022-12-15
GIF Diluent, Blood Cell Hematology Class 1 864.8200 2022-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2022-12-19
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2023-02-17
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
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
LCD Enzyme Immunoassay, Gentamicin Clinical Toxicology Class 2 862.3450 2022-12-19
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 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 2022-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2022-12-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-19
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2022-12-19
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2022-12-19
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2022-12-19
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-12-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-19
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2022-12-19
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 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
NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-19
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2022-12-19
DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet Clinical Toxicology Class 2 862.3040 2022-12-19
DAD Haptoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5460 2022-12-19

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
K850376 Terumo Medical Corp. TERUMO SENSIBEAD EIA TSH KIT 1985-03-04
K843395 Hybritech, Inc. ENCORE TSH REAGENT 1984-10-11
K854087 Organon Teknika Corp. NML TSH IRMA 1985-10-25
K151792 Siemens Healthcare Diagnostics, Inc. Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System 2015-11-20
K141999 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR TSH 2015-04-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2025 Qualigen Inc 2
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020 Roche Diagnostics Operations, Inc. 2
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Centaur XPT Immunoassay 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)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319808. Last updated year: 2026. Please use registration number 1319808 when referencing this establishment in official correspondence.
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