QBF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Propoxyphene, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3700
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA definition
- The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample.
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| Record | Firm | Date |
|---|---|---|
| First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup (K210327) | W.H.P.M., Inc. | 2021-08-12 |
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