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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 8866 Cypress Court, SAN DIEGO, CA, 92154
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3006048451
- DUNS Number
- —
Catalogue (52)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DrugConfirm Advanced™ 6 Panel Instant Drug Test | 03-5542 | FDA UDI | Class II | Active |
| ReliOn 4 Panel Home Drug Test Kit | RO-DRC004 | FDA UDI | Class II | Active |
Related Companies
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Authorities
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FDA Recalls (2)
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 |
|---|---|---|---|---|
| Jan 29, 2021 | Z-1125-2021 | — | terminated | 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). |
| Jan 29, 2021 | Z-1126-2021 | — | terminated | 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). |