Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021090658

FEI Number

3021090658

Entity Name

Ortho-Clinical Diagnostics, Inc.

City/State/Country

Carlsbad, CA, US

Establishment Address

2285 Rutherford Road, Carlsbad, CA 92008, 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

Expiration Date (Year)

2026

510(k) Number

K233688

PMA Number

N/A

All Registered Proprietary Names

Sofia 2 Lyme FIA QuickVue In-Line Strep A 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) Sofia 2 Flu + SARS Antigen FIA Walgreens At-Home COVID-19 Test Kit QuickVue COVID-19 Test CVS Health At Home COVID-19 Test Kit QuickVue RSV Test QuickVue hCG Urine Test QuickVue Dipstick Strep A QuickVue+ Strep A Sofia 2 Sofia 2 Installation Pack QuickVue+ hCG Combo Test 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 QuickVue hCG Combo Test Sofia 2 SARS Antigen+ FIA Sofia 2 SARS Antigen+ FIA Control Swab Set QuickVue Adenoviral conjunctivitis Test Sofia Strep A+ FIA Sofia Installation Pack Sofia Analyzer Sofia Influenza A+B FIA QuickVue In-Line Strep A Ctrl Set QuickVue and Sofia Dry Transport Tubes QUICKVUE IFOB TEST Sofia hCG FIA Sofia Legionella FIA hCG Control Set Sofia 2 SARS Antigen+ FIA Control Swab Set Sofia 2 SARS Antigen+ FIA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2008-08-08
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2022-12-21
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2020-11-24
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2024-04-02
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2014-01-15
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-08-08
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2008-08-08
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2008-08-08
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
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-08-08
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-11-24
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	2023-03-16
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2017-06-02
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2015-01-05
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
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2008-12-11
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-12-15
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2005-12-01
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-10-22
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2012-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	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

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
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10

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-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-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.

Similar Registrations

Registration Number	Establishment Name	Location
2024674	QUIDEL CORP.	SAN DIEGO, CA, US
2029372	Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, US
9615037	BIOMERIEUX ITALIA-INDUSTRIAL DIV.	PONTE-A EMA, FLORENCE Firenze, IT
3007208259	GOLD STANDARD DIAGNOSTICS, LLC	Davis, CA, US
3033751096	Ortho-Clinical Diagnostics, Inc.	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021090658. Last updated year: 2026. Please use registration number 3021090658 when referencing this establishment in official correspondence.