Identity
- Trade Name
- MGC HEALTH FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- MGC HEALTH™ D-PEN™ MINI COC ORAL FLUID TEST, 2T/Box FDA UDI
- Model / Reference
- 2T FDA UDI
- Description
- MGC HEALTH™ D-PEN™ MINI COC ORAL FLUID TEST, 2T/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00383173000269 FDA UDI
- FDA Product Code
- PVA FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Mgc Health by Guangzhou Decheng Biotechnology Co., LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Decheng Biotechnology Co., LTD
Sources (1)
- FDA UDI 2f020628-26c9-42d5-9b9e-a1c7e53eb075 33 fields · synced May 30, 2026