Identity
- Trade Name
- STATCUP® II FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- STATCUP II 12 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Box FDA UDI
- Model / Reference
- STATⅡ-71127-0-A FDA UDI
- Description
- STATCUP II 12 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Box FDA UDI
Identifiers
- Catalog Number
- STATⅡ-71127-0-A FDA UDI
- Primary DI / UDI-DI
- 00816036025135 FDA UDI
- FDA Product Code
- LDJ FDA UDIDKZ FDA UDIDJG FDA UDIDIO FDA UDIDKE FDA UDILCM FDA UDIDJR FDA UDIDIS FDA UDILAF FDA UDIJXM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3100 FDA UDI862.3650 FDA UDI862.3250 FDA UDI862.3620 FDA UDI862.3150 FDA UDI862.3610 FDA UDI862.3170 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
Yes
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: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Statcup® Ii by Micro Distributing, L.c — 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
- Micro Distributing, L.c
Sources (1)
- FDA UDI 56482ef5-d34a-4c81-b6ee-efcaa727af99 36 fields · synced May 30, 2026