Identity
- Trade Name
- ToxCup Drug Screen Cup FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- AMP1000/COC300/OPI2000/PCP25/THC50 Adulteration Screen for CR-NI-PH-BL-SG FDA UDI
- Model / Reference
- PT11A FDA UDI
- Description
- AMP1000/COC300/OPI2000/PCP25/THC50 Adulteration Screen for CR-NI-PH-BL-SG FDA UDI
Identifiers
- Catalog Number
- PT11A FDA UDI
- Primary DI / UDI-DI
- 00816565020779 FDA UDI
- 510(k) Number
- K032057 FDA UDI
- FDA Product Code
- LCM FDA UDIDIO FDA UDILDJ FDA UDIDJG FDA UDIDKZ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3250 FDA UDI862.3870 FDA UDI862.3650 FDA UDI862.3100 FDA UDI
- Commercial Distribution
- Not 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
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
ToxCup Drug Screen Cup by Ameditech Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Ameditech Inc.
Sources (1)
- FDA UDI 63d377c7-2a9f-4084-85a5-d75fb56e1527 38 fields · synced Jun 8, 2026