Identity
- Trade Name
- ImmuTest Drugs of Abuse Cup FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests FDA UDI
- Model / Reference
- IMCA-8BB FDA UDI
- Description
- 8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests FDA UDI
Identifiers
- Catalog Number
- IMCA-8BB FDA UDI
- Primary DI / UDI-DI
- 00816565020267 FDA UDI
- 510(k) Number
- K113046 FDA UDI
- FDA Product Code
- DIO FDA UDIDJR FDA UDIDJC FDA UDIDJG FDA UDIJXM FDA UDIDKZ FDA UDILDJ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 FDA UDI862.3620 FDA UDI862.3610 FDA UDI862.3650 FDA UDI862.3170 FDA UDI862.3100 FDA UDI862.3870 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
ImmuTest Drugs of Abuse Cup by Ameditech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K113046 also covers:
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 75d03d46-f30f-4ac8-9e7f-d47de1a95d60 38 fields · synced May 30, 2026