Identity
- Trade Name
- Wholepower FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP) FDA UDI
- Model / Reference
- 41511104001034 FDA UDI
- Description
- 10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 90857275007837 FDA UDI
- FDA Product Code
- LCM FDA UDIDIO FDA UDIJXM FDA UDIDIS FDA UDIDKZ FDA UDIDJG FDA UDIDNK FDA UDIDJC FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3250 FDA UDI862.3170 FDA UDI862.3150 FDA UDI862.3100 FDA UDI862.3650 FDA UDI862.3640 FDA UDI862.3610 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: Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalBarbiturate IVD, kit, rapid ICT, clinicalAmphetamine-specific IVD, kit, rapid ICT, clinicalMethamphetamine-specific IVD, kit, rapid ICT, clinical
Wholepower by Idun Solutions Llc — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Idun Solutions Llc
Sources (1)
- FDA UDI a821d88b-1bb6-4cef-97fa-cff893db7f24 33 fields · synced May 30, 2026