Identity
- Trade Name
- DETECTABUSE FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, reagent FDA UDI
- Device Name
- Detectabuse GV-65 3mL, SYRINGE, 100pK FDA UDI
- Model / Reference
- 14100720 FDA UDI
- Description
- Detectabuse GV-65 3mL, SYRINGE, 100pK FDA UDI
Identifiers
- Catalog Number
- 14100720 FDA UDI
- Primary DI / UDI-DI
- 00810042682436 FDA UDI
- FDA Product Code
- DKO FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2230 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Detectabuse by Biochemical Diagnostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biochemical Diagnostics Inc
Sources (1)
- FDA UDI 3cdcfed0-8dfe-4060-9d2f-f5c3b1d4e025 37 fields · synced Jun 8, 2026