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Quidel Corp.

Last updated September 17, 2026

Information

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

Catalogue (214)

Page 2 of 5

Device	Model / Reference	Registries	Class	Status
Sofia	20276	FDA UDI	Class I	Active
MicroVue	Vitamin D EIA	FDA UDI	Class II	Unknown
MicroVue	PYD EIA	FDA UDI	Class I	Active
Lyra	Direct HSV 1+2/VZV Assay	FDA UDI	Class II	Active
Solana	Trichomonas Assay	FDA UDI	Class II	Active
QuickVue	20387	FDA UDI	N	Active
MicroVue	CIC-Raji EIA	FDA UDI	Class II	Active
AmpliVue	GBS Assay	FDA UDI	Class I	Unknown
Sofia	20319	FDA UDI	Class II	Active
MicroVue	CIC-C1q EIA	FDA UDI	Class II	Active
Sofia	20299R	FDA UDI	Class I	Active
InflammaDry	RPS-ID-20-U	FDA UDI	Class I	Active
Solana	Trichomonas Assay	FDA UDI	Class II	Active
AmpliVue	HSV 1+2 Assay	FDA UDI	Class II	Unknown
Sofia	hCG FIA	FDA UDI	Class II	Active
QuickVue	20193	FDA UDI	Class I	Active
QuickVue	20163	FDA UDI	Class I	Active
QuickVue+	hCG S/U Test	FDA UDI	Class II	Active
Lyra	Direct Strep Assay	FDA UDI	Class II	Active
Solana	20278	FDA UDI	Class II	Active
MicroVue	DPD EIA	FDA UDI	Class I	Active
QuickVue	20183	FDA UDI	Class I	Active
QuickVue	20108	FDA UDI	Class I	Active
QuickVue	00272	FDA UDI	Class I	Active
Lyra	Parainfluenza Virus Assay	FDA UDI	Class II	Active
QuickVue	20398	FDA UDI	N	Active
QuickVue	One-Step hCG Combo Test	FDA UDI	Class II	Active
QuickVue	00281	FDA UDI	Class I	Active
QuickVue	00354	FDA UDI	Class I	Active
Lyra	Direct C. difficile Assay	FDA UDI	Class II	Active
Sofia	20299	FDA UDI	Class I	Active
MicroVue	CH50 Eq EIA	FDA UDI	Class II	Active
MicroVue	BAP EIA	FDA UDI	Class II	Active
Cards Q.s. Strep A	K955108	FDA 510(k)	Class I	Active
Quickvue(tm) One-Step Hcg Controls (posit/Negati)	K931761	FDA 510(k)	Class I	Active
Sofia Influenza A+B FIA	K153012	FDA 510(k)	Class II	Active
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument	K232286	FDA 510(k)	Class II	Active
Quickvue Influenza A + B Test	K053146	FDA 510(k)	Class II	Active
Quickvue One-Step Hcg-Combo	K973841	FDA 510(k)	Class II	Active
Solana Bordetella Complete Assay	K181029	FDA 510(k)	Class II	Active
Solana Strep Complete Assay	K162274	FDA 510(k)	Class II	Active
Quidel Hcg Test	K894790	FDA 510(k)	Class II	Active
Quidel Total Ige Positive Control Serum	K905162	FDA 510(k)	Class II	Active
Quidel Beta Hcg Enzyme Immunoassay Kit	K842692	FDA 510(k)	Class II	Active
Sofia(r) Hcg Fia	K131166	FDA 510(k)	Class II	Active
Quidel Helicobacter Pylori Test	K903099	FDA 510(k)	Class I	Active
Quidel Reflectance Analyzer	K893738	FDA 510(k)	Class I	Active
Quickvue In-Line One-Step Strep A Control Swabs (positive & Negative Swab Specimens)	K945080	FDA 510(k)	Class I	Active
Home Pregnancy Test Kit	K831108	FDA 510(k)	Class II	Active
Group A Strep Positive And Negative Controls	K912868	FDA 510(k)	Class I	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.