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Quidel Corp.

Last updated September 17, 2026

Information

Country: US
Address: 10165 MCKELLAR CT., SAN DIEGO, CA, 92121
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2024674
DUNS Number: —

Catalogue (214)

Page 3 of 5

Device	Model / Reference	Registries	Class	Status
Cameo Home Pregnancy Test	K954364	FDA 510(k)	Class II	Active
Lyra Influenza A+B Assay	K230236	FDA 510(k)	Class II	Active
Quidel Total Ige Test Quantitative Version	K894039	FDA 510(k)	Class II	Active
Quidel Food Allergen Screen	K894253	FDA 510(k)	Class II	Active
Lyra Parainfluenza Virus Assay	K141927	FDA 510(k)	Class II	Active
Quickvue One-Step Hcg-Urine	K020799	FDA 510(k)	Class II	Active
Quickvue One-Step Hcg Combo	K932042	FDA 510(k)	Class II	Active
Qtest(tm) Pregnancy	K882086	FDA 510(k)	Class II	Active
Cards Q.s. Hcg Or Concise Performance Plus Hcg	K954273	FDA 510(k)	Class II	Active
Amplivue C. Difficile Assay	K123355	FDA 510(k)	Class II	Active
Quidel Molecular Rsv + Hmpv Assay	K131813	FDA 510(k)	Class II	Active
Bluetest(r) Pregnancy Test, Rapidvue(r) Pregnancy Test	K974821	FDA 510(k)	Class II	Active
Quest Beta Hcg Enzyme Immunoassay Kit	K844082	FDA 510(k)	Class II	Active
Directigen 1-2-3(tm) Hcg Test	K913122	FDA 510(k)	Class II	Active
Quidel Molecular Influenza A + B Assay	K112172	FDA 510(k)	Class II	Active
Quickvue Rsv (20 Test Kit), Model 20193; (2 Test Kit), Model 20199	K061008	FDA 510(k)	Class I	Active
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set	DEN220039	FDA 510(k)	Class II	Active
Directigen 1-2-3 Infectious Mononucleosis Test	K893737	FDA 510(k)	Class II	Active
Quidel Total Ige Test	K875168	FDA 510(k)	Class II	Active
Lyra Adenovirus Assay	K141931	FDA 510(k)	Class II	Active
Solana C. difficile Assay	K170491	FDA 510(k)	Class II	Active
Quidel Group A Strep Test	K883999	FDA 510(k)	Class I	Active
Quickvue One-Step H. Pylori Ii Test	K991747	FDA 510(k)	Class I	Active
Solana GBS Assay	K173250	FDA 510(k)	Class I	Active
Quickvue Influenza A+b Test	K092698	FDA 510(k)	Class II	Active
Sofia Strep A+ FIA, Sofia 2 Analyzer	K171976	FDA 510(k)	Class I	Active
Quidel Chlamydia Test	K901660	FDA 510(k)	Class I	Active
Quidel Beta Stick Pregnancy Test (modification)	K862207	FDA 510(k)	Class II	Active
Directigen 1-2-3 Pregnancy Controls	K911664	FDA 510(k)	Class I	Active
Sofia RSV FIA on Sofia 2 analyzer	K162911	FDA 510(k)	Class I	Active
Quick Vue Influenza	K131599	FDA 510(k)	Class I	Active
Qtest Strep	K872961	FDA 510(k)	Class I	Active
Quidel Food Allergy Screen	K884501	FDA 510(k)	Class II	Active
Qtest Pregnancy Test Control	K883741	FDA 510(k)	Class I	Active
Quickvue One-Step Hcg-Urine	K972742	FDA 510(k)	Class II	Active
Ph And Amines External Control Set	K022851	FDA 510(k)	Class I	Active
AmpliVue Bordetella Assay	K143206	FDA 510(k)	Class II	Active
Rapidvue Hcg Test	K102175	FDA 510(k)	Class II	Active
Quidel Home Pregnancy Test	K981722	FDA 510(k)	Class II	Active
Sofia (r) Strep A+ Fia	K141775	FDA 510(k)	Class I	Active
Quickvue One-Step Helicobactor Pylori Test	K952517	FDA 510(k)	Class I	Active
Quidel Hcg Enzyme Immunoassay Kit	K833156	FDA 510(k)	Class II	Active
Quidel Helicobacter Pylori Microwell Eia Test	K912442	FDA 510(k)	Class I	Active
Quickvue Dipstick Strep A	K011097	FDA 510(k)	Class I	Active
Quidel Molecular Direct C. Difficile Assay	K123998	FDA 510(k)	Class II	Active
Quidel Quest Ovulation Test	K852146	FDA 510(k)	Class I	Active
Quidel Allergy Screen	K874717	FDA 510(k)	Class II	Active
Quidel Quest Strep Group A Test	K852806	FDA 510(k)	Class I	Active
Quidel Allergy Screen	K883666	FDA 510(k)	Class II	Active
Lyra Direct Strep Assay	DEN140005	FDA 510(k)	Class II	Active

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FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 6, 2026	Z-2169-2026	—	open, classified	Product has the potential for false positive results
Jun 17, 2025	Z-2545-2025	—	open, classified	Dipstick strep A test has potential for false positive results.
Mar 5, 2024	Z-1636-2024	—	open, classified	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.
Mar 5, 2024	Z-1637-2024	—	open, classified	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.
Jan 3, 2024	Z-1086-2024	—	open, classified	One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.
Feb 1, 2023	Z-1308-2023	—	open, classified	Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Aug 13, 2021	Z-2477-2021	—	terminated	Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene MDx.
Apr 27, 2021	Z-1928-2021	—	terminated	In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
Sep 25, 2020	Z-0428-2021	—	terminated	Due to false positive results.
Sep 17, 2020	Z-0124-2021	—	terminated	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.
Dec 15, 2017	Z-1183-2018	—	terminated	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.
Jun 22, 2017	Z-2803-2017	—	terminated	In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Jan 25, 2017	Z-1231-2017	—	terminated	Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.
Dec 3, 2012	Z-0819-2013	—	terminated	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.
Nov 23, 2010	Z-1457-2011	—	terminated	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.