Data / Medical devices / United States / Confirm Biosciences LLC
Confirm Biosciences LLC: FDA-registered device maker in San Diego, CA, United States, 6 510(k) clearances
Confirm Biosciences LLC is registered with the FDA (registration 3006048451) in San Diego, CA, United States. It lists 30 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 7, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006048451
- Address
- 8866 Cypress Court Building E, San Diego, CA, United States, 92154
- Owner or operator
- Confirm Biosciences LLC (9095540)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- December 12, 2006
- Registered through
- 2026
- Brand names listed
- Accurate Multi Panel Drug Urine Test Cup, DrugConfirm Urine Drug Test Kits, Drugconfirm, Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card, HealthConfirm Covid Flu A/B (OTC), PREGNANCY ONE STEP RAPID TEST, Test, cannabinoid, employment and insurance testing, exempt, Test, methaqualone, employment and insurance testing, exempt and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 7, 2024 | DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | SCA | Unknown | Healgen | accessdata.fda.gov |
| April 12, 2024 | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| August 7, 2019 | K191841 | Accurate Multi Panel Drug Urine Test Cup | NFT | Substantially Equivalent | Healstone Biotech, Inc. | accessdata.fda.gov |
| August 2, 2017 | K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| May 23, 2016 | K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| July 28, 2011 | K103574 | PREGNANCY ONE STEP RAPID TEST | LCX | Substantially Equivalent | Lehnus & Associates Consulting | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 29, 2021 | 87263 | Class II | Terminated | Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies t | Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing). | accessdata.fda.gov |
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Updated October 7, 2024. 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.