Data / Medical devices / United States / Quidel Corp.

Quidel Corp.: FDA-registered device maker in San Diego, CA, United States, 25 510(k) clearances

Name: Quidel Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Quidel Corp. is registered with the FDA (registration 2024674) in San Diego, CA, United States. It lists 23 device types. The FDA files 25 510(k) clearances under its listings, the newest dated December 20, 2023. 10 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Quidel Corp.

FDA registration number: 2024674
Address: 10165 Mckellar CT., San Diego, CA, United States, 92121
Owner or operator: QuidelOrtho Corporation (2024674)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export
First device listed: December 22, 1992
Registered through: 2026
Brand names listed: InflammaDry, QUICKVUE IFOB TEST, QuickVue Adenoviral conjunctivitis Test, QuickVue At Home COVID-19, QuickVue Dipstick Strep A, QuickVue In-Line Strep A, QuickVue In-Line Strep A Ctrl Set, QuickVue Influenza A+B and more

Devices it lists

Device	Product code	Class	Role	Source
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	GQG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.	GTY	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antigens, Cf (Including Cf Control), Adenovirus 1-33	GOD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.	GTZ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	PMN	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Assayed Quality Control Material For Clinical Microbiology Assays	QCH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Campylobacter Spp.	LQP	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Manufacturer	accessdata.fda.gov
Covid-19 Multi-Analyte Antigen Device	QMN	N	Manufacturer	accessdata.fda.gov
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	QLT	N	Manufacturer for export	accessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus Antigens	PSZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Fluorometer, For Clinical Use	KHO	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	PGI	2	Manufacturer	accessdata.fda.gov
Mmp-9 Test System	PFQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reagent, Borrelia Serological Reagent	LSR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	LHL	2	Manufacturer for export	accessdata.fda.gov
Reagents, Clostridium Difficile Toxin	LLH	1	Manufacturer for export	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer	accessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	QVF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 20, 2023	K232286	Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument	PGI	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
December 13, 2023	K233688	Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set	QVF	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
March 8, 2023	DEN220039	Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set	QVF	Unknown	Quidel Corporation	accessdata.fda.gov
November 23, 2021	K211342	Sofia 2 Campylobacter FIA	LQP	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
August 30, 2018	K173496	Sofia 2 Lyme FIA, Sofia Lyme Control Set	LSR	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
October 20, 2017	K163713	Sofia Lyme FIA, Sofia Lyme Control Set	LSR	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
February 22, 2017	K162911	Sofia RSV FIA on Sofia 2 analyzer	GQG	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
December 16, 2014	K141775	SOFIA (R) STREP A+ FIA	GTY	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
November 21, 2013	K132066	INFLAMMA DRY	PFQ	Substantially Equivalent	Rapid Pathogen Screening, Inc.	accessdata.fda.gov
August 13, 2013	K130398	SOFIA(R) RSV FIA	GQG	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
October 24, 2011	K112177	SOFIA ANALYZER AND INFLUENZA A+B FIA	PSZ	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
May 17, 2011	K110722	RPS ADENO DETECTOR PLUS	GOD	Substantially Equivalent	Rapid Pathogen Screening, Inc.	accessdata.fda.gov
April 23, 2007	K070747	QUICK VUE RSV TEST, MODELS 20193, 20199	GQG	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
December 14, 2005	K053146	QUICKVUE INFLUENZA A + B TEST	PSZ	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
June 17, 2002	K021423	INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST	KHE	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
May 17, 2002	K020801	QUICKVUE ONE-STEP HCG-COMBO	JHI	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
May 17, 2002	K020799	QUICKVUE ONE-STEP HCG-URINE	JHI	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
May 8, 2001	K011097	QUICKVUE DIPSTICK STREP A	GTY	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
November 26, 1997	K974108	SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)	JJX	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
November 26, 1997	K973858	CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO	JHI	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
April 15, 1996	K955108	CARDS Q.S. STREP A	GTZ	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
February 10, 1995	K945080	QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)	GTY	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
July 18, 1994	K934484	QUICKVUE IN-LINE ONE-STEP STREP A TEST	GTZ	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
June 22, 1993	K931761	QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)	JJX	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov
August 7, 1991	K912868	GROUP A STREP POSITIVE AND NEGATIVE CONTROLS	GTZ	Substantially Equivalent	Quidel Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 6, 2026	98709	Class II	Ongoing	QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.	Product has the potential for false positive results	accessdata.fda.gov
June 17, 2025	97271	Class II	Ongoing	QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC	Dipstick strep A test has potential for false positive results.	accessdata.fda.gov
March 5, 2024	94219	Class II	Ongoing	QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests	There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.	accessdata.fda.gov
September 25, 2020	86550	Class II	Terminated	QUIDEL Sofia SARS Antigen FIA IVD REF 20374	Due to false positive results.	accessdata.fda.gov
September 17, 2020	86276	Class II	Terminated	Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleoc	Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.	accessdata.fda.gov
December 15, 2017	79271	Class II	Terminated	Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays. Sofia 2 is intended for professional and laboratory use.	The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.	accessdata.fda.gov
June 22, 2017	77640	Class II	Terminated	InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patien	In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.	accessdata.fda.gov
January 25, 2017	76337	Class II	Terminated	Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests	Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.	accessdata.fda.gov
December 3, 2012	64017	Class II	Terminated	Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.	Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.	accessdata.fda.gov
November 23, 2010	57402	Not yet classified	Terminated	QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842	The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit boxes. These foil pouches and test cassettes are clearly labeled as H. pylori. Nevertheless, there is a risk that customers may overlook this labeling.	accessdata.fda.gov

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Updated May 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.