Identity
- Trade Name
- ImmuTest Drugs of Abuse Screen Card FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Immutest MET+THC Test Card with Cr, Ni, pH, Bl, S.G. adulteration test FDA UDI
- Model / Reference
- IMDA-2AMJ FDA UDI
- Description
- Immutest MET+THC Test Card with Cr, Ni, pH, Bl, S.G. adulteration test FDA UDI
Identifiers
- Catalog Number
- IMDA-2AMJ FDA UDI
- Primary DI / UDI-DI
- 00816565021288 FDA UDI
- 510(k) Number
- K113046 FDA UDI
- FDA Product Code
- DJC 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
- 862.3610 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 Screen Card 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 d3e87a54-c2e2-4988-87a0-a1dba8f5376e 38 fields · synced May 30, 2026