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Sign in to claim this brandQuidel Corp.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 10165 MCKELLAR CT., SAN DIEGO, CA, 92121
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2024674
- DUNS Number
- —
Catalogue (214)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lyra RSV+hMPV Assay | K230349 | FDA 510(k) | Class II | Active |
| Amplivue Gbs Assay | K133503 | FDA 510(k) | Class I | Active |
| Quickvue Influenza A+b | K131619 | FDA 510(k) | Class I | Active |
| Sofia(r) Rsv Fia | K130398 | FDA 510(k) | Class I | Active |
| Lh Gen Iii Self-Test/Conceive | K920160 | FDA 510(k) | Class I | Active |
| Sofia Lyme FIA, Sofia Lyme Control Set | K163713 | FDA 510(k) | Class II | Active |
| Quidel Pregnancy Test | K881595 | FDA 510(k) | Class II | Active |
| Quidel Helicobacter Pylori Postive/Negative Contr | K905049 | FDA 510(k) | Class I | Active |
| Quidel Chlamydia Positive Control | K903765 | FDA 510(k) | Class I | Active |
| Quickvue Semi-Q Hcg-Combo | K974052 | FDA 510(k) | Class II | Active |
| Rapidvue(tm) Hcg | K945969 | FDA 510(k) | Class II | Active |
| Quidel Ch50 Eq Eia | K974111 | FDA 510(k) | Class II | Active |
| Solana Trichomonas Assay | K161182 | FDA 510(k) | Class II | Active |
| Quidel Molecular Rsv + Hmpv Assay | K122189 | FDA 510(k) | Class II | Active |
| QuickVue COVID-19 Test | K231795 | FDA 510(k) | Class II | Active |
| Quickvue In-Line One-Step Strep A Test | K934484 | FDA 510(k) | Class I | Active |
| Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | K173691 | FDA 510(k) | Class II | Active |
| Quickvue One-Step Allergen Screen | K950728 | FDA 510(k) | Class II | Active |
| Amplivue Gas Assay | K141173 | FDA 510(k) | Class II | Active |
| AmpliVue Trichomonas Assay | K143329 | FDA 510(k) | Class II | Active |
| Sofia Influenza A+B FIA on Sofia 2 | K162438 | FDA 510(k) | Class II | Active |
| Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | K233688 | FDA 510(k) | Class II | Active |
| Quick Vue Rsv Test, Models 20193, 20199 | K070747 | FDA 510(k) | Class I | Active |
| Sofia Analyzer And Influenza A+b Fia | K112177 | FDA 510(k) | Class II | Active |
| Quickvue One-Step Hcg Test | K925435 | FDA 510(k) | Class II | Active |
| Sofia 2 Lyme FIA, Sofia Lyme Control Set | K173496 | FDA 510(k) | Class II | Active |
| Positive Control Pad Allergen/Food Allergen Screen | K905176 | FDA 510(k) | Class II | Active |
| Conceive One-Step Pregnancy Test | K925096 | FDA 510(k) | Class II | Active |
| Quidel Quickvue H. Pylori Controls (pos. And Neg) | K915851 | FDA 510(k) | Class I | Active |
| Beta Stick, Pregnancy Test | K841415 | FDA 510(k) | Class II | Active |
| Serum Hcg Control Set (negative, Low Positive And High Positive) | K974108 | FDA 510(k) | Class I | Active |
| Positive Control Pad For Total Ige Test Dipstick | K910082 | FDA 510(k) | Class II | Active |
| Quidel Food Allergen Screen - Barley Allergen | K892409 | FDA 510(k) | Class II | Active |
| Amiplivue Hsv 1&2 Assay | K140029 | FDA 510(k) | Class II | Active |
| Sofia Strep A Fia | K123793 | FDA 510(k) | Class I | Active |
| Directigen1-2-3 Bhcg Pregnancy Test | K890615 | FDA 510(k) | Class II | Active |
| Quickvue Advance Ph And Amines Gll Test | K040008 | FDA 510(k) | Class I | Active |
| Quickvue(r) Chlamydia Test | K946276 | FDA 510(k) | Class I | Active |
| Quidel Group B Strep Test | K896265 | FDA 510(k) | Class I | Active |
| Solana RSV+hMPV Assay | K171974 | FDA 510(k) | Class II | Active |
| Quidel Allergen Screen Positive Control | K903738 | FDA 510(k) | Class II | Active |
| Quidel Molecular Influenza A+b | K113777 | FDA 510(k) | Class II | Active |
| Solana HSV 1+2/VZV Assay | K162451 | FDA 510(k) | Class II | Active |
| Early Pregnancy Detection Test Kit | K833466 | FDA 510(k) | Class II | Active |
| Quidel Molecular Hmpv Assay | K112490 | FDA 510(k) | Class II | Active |
| Home Pregnancy Test Kit Hpk #1 | K831051 | FDA 510(k) | Class II | Active |
| Solana GAS Assay, Solana instrument | K150868 | FDA 510(k) | Class II | Active |
| Cards Q.s. Hcg Serum/Urine;concise Performance Plus Hcg-Combo | K973858 | FDA 510(k) | Class II | Active |
| Quidel Allergy Screen | K861171 | FDA 510(k) | Class II | Active |
| Quickvue Influenza A/B Test | K991633 | 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. |