Identity
- Trade Name
- Healgen (Private Label) - 254 FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 5 Panel Clia Cup COC/THC/OPI/AMP/mAMP FDA UDI
- Model / Reference
- CB-HE-CUP-254 FDA UDI
- Description
- 5 Panel Clia Cup COC/THC/OPI/AMP/mAMP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00895330002806 FDA UDI
- FDA Product Code
- NFT FDA UDINFY FDA UDINGG FDA UDINGL FDA UDINFW FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3250 FDA UDI862.3610 FDA UDI862.3650 FDA UDI862.3870 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
No
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: Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinicalCannabinoid/cannabinoid metabolite IVD, reagentCocaine/cocaine metabolite IVD, reagentOpiate/opiate metabolite IVD, reagent
Healgen (Private Label) - 254 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 949ea72a-b999-4f88-b637-f27685e478af 33 fields · synced May 30, 2026