QBFClass II
Test, Propoxyphene, Over The Counter
21 CFR 862.3700 / Clinical Toxicology
QBF is the FDA product code for Test, Propoxyphene, Over The Counter, a class II device type, regulated under 21 CFR 862.3700. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QBF
- Device name
- Test, Propoxyphene, Over The Counter
- 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.
- Regulation
- 21 CFR 862.3700
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QBF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
Applicants with the most clearances
Product code QBF| Applicant | Clearances |
|---|---|
| WHPM Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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