Identity
- Trade Name
- Instant Test Cup FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with Adulteration OX/SG/pH Drugs of Abuse Test Cup (CLIA WAIVED) FDA UDI
- Model / Reference
- 10-300 FDA UDI
- Description
- COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with Adulteration OX/SG/pH Drugs of Abuse Test Cup (CLIA WAIVED) FDA UDI
Identifiers
- Catalog Number
- 10-300 FDA UDI
- Primary DI / UDI-DI
- 00816565020625 FDA UDI
- 510(k) Number
- K082898 FDA UDI
- FDA Product Code
- DJG FDA UDINFV 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
- 862.3650 FDA UDI862.3170 FDA UDI862.3610 FDA UDI862.3100 FDA UDI862.3250 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
No
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
Instant Test Cup by Ameditech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K082898 also covers:
- Alere iCup DX Pro — Instant Technologies, Inc.
- Alere iCup Dx Pro — Instant Technologies, Inc.
- Alere iCup Dx Pro — Instant Technologies, Inc.
- Accutest — JANT PHARMACAL CORP.
- Accutest — JANT PHARMACAL CORP.
- Accutest — JANT PHARMACAL CORP.
- NexScreen Cup — NEXSCREEN, LLC
- 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 6131e877-811e-4d87-a536-82d7e384f8e2 38 fields · synced May 30, 2026