PTH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Barbiturate, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA definition
- The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K180255) | Hangzhou Clongene Biotech Co., Ltd. | 2018-02-28 | + Add |
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