Identity
- Trade Name
- DrugConfirm™ Single Panel Marijuana Testing Kit FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that want a fast and accurate instant drug test which is easy to perform from the privacy of your home to detect marijuana usage. FDA UDI
- Model / Reference
- 03-5601 FDA UDI
- Description
- DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that want a fast and accurate instant drug test which is easy to perform from the privacy of your home to detect marijuana usage. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00895330002264 FDA UDI
- FDA Product Code
- DKE FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
DrugConfirm™ Single Panel Marijuana Testing Kit by Confirm Biosciences LLC — 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
- Confirm Biosciences LLC
Sources (1)
- FDA UDI 2335f629-edcd-4fe8-9309-4d8e94ea46d9 33 fields · synced May 30, 2026