Cards Q.S. Hcg or Concise Performance Plus Hcg
FDA 510(k)Class II (US FDA 510(k))
by Quidel Corp.
Identifiers
- 510(k) Number
- K954273 FDA 510(k)
- FDA Product Code
- JHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1155 FDA 510(k)
- Regulation Number
- 862.1155 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cards Q.S. Hcg or Concise Performance Plus Hcg is a visual human chorionic gonadotropin (hCG) test system. It is designed for the qualitative detection of hCG, a placental hormone, in urine to aid in the early detection of pregnancy.
This device is intended for prescription use and is regulated under 21 CFR 862.1155. It has received FDA 510(k) clearance as a substantially equivalent clinical chemistry device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cards Q.s. Hcg Serum/Urine;Concise Performance Plus Hcg-combo (K973858 ..., PDF nje5361 - Food and Drug Administration, Cards Q.s. Hcg-urine; and Concise Performance Plus Hcg-urine
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954273 | Class II | Active |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA 510(k) K954273 24 fields · synced Sep 21, 2026