Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2024674

FEI Number

2024674

Entity Name

QUIDEL CORP.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

10165 MCKELLAR CT., SAN DIEGO, CA 92121, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

K130398

PMA Number

N/A

All Registered Proprietary Names

Sofia S. pneumoniae FIA Sofia 2 Flu + SARS Antigen FIA Sofia Lyme FIA QuickVue Dipstick Strep A Savanna RVP4 Assay QuickVue Adenoviral conjunctivitis Test Sofia 2 Lyme FIA QuickVue RSV Test Savanna HSV 1+2/VZV Control Set Savanna Instrument Savanna HSV 1+2/VZV Assay QuickVue hCG Combo Test Sofia Legionella FIA QuickVue+ Strep A Sofia 2 SARS Antigen+ FIA Control Swab Set Sofia 2 SARS Antigen+ FIA Strep A Liquid Control Set hCG Control Set QuickVue RSV Test QuickVue In-Line Strep A Sofia hCG FIA QUICKVUE IFOB TEST QuickVue and Sofia Dry Transport Tubes QuickVue RSV 10 Serum hCG Control Set Sofia 2 Sofia 2 Installation Pack Sofia 2 C. difficile FIA QuickVue Influenza A+B Sofia RSV FIA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	1992-12-22
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2020-11-24
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2017-10-23
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2008-08-08
QLT	Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	Unknown	Class N	N/A	2022-05-09
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2017-06-02
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
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2014-01-15
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2024-01-26
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-01-26
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2024-01-26
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-08-08
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2012-12-19
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	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
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2008-12-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-08-08
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2014-01-15
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2008-08-08
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-10-22
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2005-12-01
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-12-15
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2011-04-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-12-11
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
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2021-12-09
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2008-08-08
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2013-10-22

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
3012963943	Ortho Clinical Diagnostics, K.K.	Shinagawa-ku Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31
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
K820822	Hybritech, Inc.	TANDEM HCG KIT	1982-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2025	Luminex Molecular Diagnostics Inc	N	NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
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-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

Registration Number	Establishment Name	Location
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
9611882	SSI Diagnostica A/S	Hilleroed Hovedstaden, DK
3004635103	GUANGZHOU WONDFO BIOTECH CO., LTD.	Guangzhou Guangdong, CN
3017772438	Sekisui Diagnostics, LLC	San Diego, CA, US
3005360469	ACRO BIOTECH Inc.	Montclair, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024674. Last updated year: 2026. Please use registration number 2024674 when referencing this establishment in official correspondence.