Identity
- Trade Name
- AmediCheck Instant Test Cup FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY Drugs of Abuse Test Cup FDA UDI
- Model / Reference
- C-C1016A FDA UDI
- Description
- THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY Drugs of Abuse Test Cup FDA UDI
Identifiers
- Catalog Number
- C-C1016A FDA UDI
- Primary DI / UDI-DI
- 00816565020564 FDA UDI
- FDA Product Code
- LDJ FDA UDINFW FDA UDIJXM FDA UDIDKZ FDA UDIDIO FDA UDIDJG FDA UDIDJR FDA UDINFV FDA UDIDIS FDA UDIDJC FDA UDINGG FDA UDINFT FDA UDINGL FDA UDINFY 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 UDI862.3170 FDA UDI862.3100 FDA UDI862.3250 FDA UDI862.3650 FDA UDI862.3620 FDA UDI862.3150 FDA UDI862.3610 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
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
AmediCheck Instant Test Cup by Ameditech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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- NexScreen Cup — NEXSCREEN, LLC
- NexScreen Cup — NEXSCREEN, LLC
- NexScreen Cup — NEXSCREEN, LLC
- NexScreen Cup — NEXSCREEN, LLC
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 c21fba5e-31ec-4c6f-afe2-2c9b3e13c9d0 38 fields · synced May 31, 2026