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/BAR300/BZO300/MTD300/OXY100/OPI300 Adulteration Screen for CR-NI-PH-BL-SG FDA UDI
- Model / Reference
- HT32A FDA UDI
- Description
- AMP1000/COC300/BAR300/BZO300/MTD300/OXY100/OPI300 Adulteration Screen for CR-NI-PH-BL-SG FDA UDI
Identifiers
- Catalog Number
- HT32A FDA UDI
- Primary DI / UDI-DI
- 00816565020755 FDA UDI
- 510(k) Number
- K032057 FDA UDI
- FDA Product Code
- DJR FDA UDIDIO FDA UDIDIS FDA UDIJXM FDA UDIDKZ FDA UDIDJG FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI862.3250 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3100 FDA UDI862.3650 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 II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ameditech Inc.
Sources (1)
- FDA UDI 43933ad6-5038-4261-af5c-4df68781c3b7 38 fields · synced May 30, 2026