Identity
- Trade Name
- Healgen (Private Label) 6125A3 FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, reagent FDA UDI
- Device Name
- Healgen (DrugConfirm) - 12 Panel AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50/Adulterants (CR/SG/OX) FDA UDI
- Model / Reference
- CB-HE-CUP-6125A3C FDA UDI
- Description
- Healgen (DrugConfirm) - 12 Panel AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50/Adulterants (CR/SG/OX) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00895330002851 FDA UDI
- FDA Product Code
- NGL FDA UDINFT FDA UDIPTH FDA UDINFV FDA UDINFY FDA UDINGG FDA UDIPTG FDA UDINGM FDA UDINFW FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3100 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3610 FDA UDI862.3620 FDA UDI862.3870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Barbiturate IVD, kit, rapid ICT, clinicalAmphetamine/methamphetamine group IVD, kit, rapid ICT, clinicalCannabinoid/cannabinoid metabolite IVD, reagentCocaine/cocaine metabolite IVD, reagent
Healgen (Private Label) 6125A3 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 d7faa0be-f213-4af1-bc62-4f99104a78d7 33 fields · synced May 30, 2026