QBK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Meprobamate Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3590
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA definition
- A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (K190397) | Immunalysis Corporation | 2019-11-15 | + Add |
| LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (DEN170010) | Lin-Zhi International, Inc. | 2018-04-20 |
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