Identity
- Trade Name
- N/M FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 12 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/BAR/BZO/MTD/MDMA/OXY/BUP) FDA UDI
- Model / Reference
- 12511315000034 FDA UDI
- Description
- 12 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/BAR/BZO/MTD/MDMA/OXY/BUP) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857275007797 FDA UDI
- FDA Product Code
- LDJ FDA UDIDIO FDA UDIDNK FDA UDIDKZ FDA UDIDJC FDA UDILCM FDA UDIDIS FDA UDIJXM FDA UDIDJR FDA UDIDJG FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3250 FDA UDI862.3640 FDA UDI862.3100 FDA UDI862.3610 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3620 FDA UDI862.3650 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
Yes
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, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalAmphetamine-specific IVD, kit, rapid ICT, clinicalBarbiturate IVD, kit, rapid ICT, clinical
N/M by Idun Solutions 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
- Idun Solutions Llc
Sources (1)
- FDA UDI a66b31e1-23a3-4dbd-a737-27a859deb3fe 33 fields · synced May 30, 2026