Identity
- Trade Name
- Accutest FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO, OPI300 (CLIA Waived) FDA UDI
- Model / Reference
- DS93S624 FDA UDI
- Description
- Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO, OPI300 (CLIA Waived) FDA UDI
Identifiers
- Catalog Number
- DS93S624 FDA UDI
- Primary DI / UDI-DI
- 10763924093639 FDA UDI
- 510(k) Number
- K082898 FDA UDI
- FDA Product Code
- NGL FDA UDINFV FDA UDINFT FDA UDINFY FDA UDINFW 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 UDI862.3100 FDA UDI862.3250 FDA UDI862.3870 FDA UDI
- Commercial Distribution
- 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
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Accutest by Jant Pharmacal Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.
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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.
- 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
- Jant Pharmacal Corp.
Sources (1)
- FDA UDI d74218fa-a0e6-45ce-b604-41d994fa14e7 37 fields · synced May 30, 2026