Ortho-Clinical Diagnostics, Inc.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3033751096

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
3033751096
FEI Number
3033751096
Entity Name
Ortho-Clinical Diagnostics, Inc.
City/State/Country
San Diego, CA, US
Establishment Address
9975 Summers Ridge Rd, San Diego, CA 92121, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K141775
PMA Number
N/A

All Registered Proprietary Names

Walgreens At-Home COVID-19 Test Kit QuickVue COVID-19 Test CVS Health At Home COVID-19 Test Kit hCG Control Set Sofia Lyme FIA Sofia Installation Pack Sofia Analyzer Sofia Influenza A+B FIA QuickVue+ hCG Combo Test Sofia 2 SARS Antigen+ FIA Control Swab Set Sofia 2 SARS Antigen+ FIA Sofia RSV FIA QuickVue In-Line Strep A Ctrl Set Sofia 2 Lyme FIA Sofia 2 Campylobacter FIA Sofia 2 QuickVue hCG Combo Test Strep A Liquid Control Set InflammaDry QuickVue Dipstick Strep A QuickVue hCG Urine Test QuickVue Influenza A+B QuickVue+ Strep A 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 Sofia 2 Sofia 2 Installation Pack Sofia Legionella FIA Sofia hCG FIA Sofia 2 C. difficile FIA Sofia 2 SARS Antigen+ FIA Sofia 2 SARS Antigen+ FIA Control Swab Set Sofia S. pneumoniae FIA QuickVue RSV Test Sofia Strep A+ FIA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QYT Over-The-Counter Covid-19 Antigen Test Microbiology Class 2 866.3984 2024-04-02
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-08-08
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2017-10-23
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2012-02-28
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2012-02-28
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-08-08
QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings Microbiology Class 2 866.3982 2024-07-30
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2013-10-22
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2008-12-11
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2018-08-31
QCH Assayed Quality Control Material For Clinical Microbiology Assays Microbiology Class 2 866.3920 2018-08-31
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2021-12-01
LQP Campylobacter Spp. Microbiology Class 1 866.3110 2021-12-01
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-08-08
GTZ Antisera, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2008-12-11
PFQ Mmp-9 Test System Clinical Chemistry Class 1 862.1540 2017-06-02
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-06-02
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2008-08-08
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-08-08
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2008-08-08
GTZ Antisera, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2008-08-08
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2020-11-24
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2017-03-23
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2017-03-23
LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent Microbiology Class 2 866.3300 2012-12-19
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2013-10-22
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2021-12-09
QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings Microbiology Class 2 866.3982 2023-03-16
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 1992-12-22
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2014-01-15
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2015-01-05

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
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K241317 Guangzhou Wondfo Biotech Co., Ltd. Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) 2024-09-30
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0006-05 Abbott Health Products, Inc. 2
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0001-2023 Jiangsu Well Biotech Co., Ltd. No N
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Z-0015-2014 Sekisui Diagnostics LLC 1
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033751096. Last updated year: 2026. Please use registration number 3033751096 when referencing this establishment in official correspondence.
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