Identity
- Trade Name
- ACCUTEST Drug Test Cup 11-Panel CLIA-Waived FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- ACCUTEST Drug Test Cup 11-Panel CLIA-Waived AMP 1000, BAR 300, BZO 300, COC 300, MAD 300, MET 1000, OPI 2000, OXY, PCP 25, TCA 1000 ,THC 50 FDA UDI
- Model / Reference
- DS811 FDA UDI
- Description
- ACCUTEST Drug Test Cup 11-Panel CLIA-Waived AMP 1000, BAR 300, BZO 300, COC 300, MAD 300, MET 1000, OPI 2000, OXY, PCP 25, TCA 1000 ,THC 50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10763924811530 FDA UDI
- 510(k) Number
- K071489 FDA UDI
- FDA Product Code
- LCM FDA UDILFH FDA UDILDJ FDA UDIDJG FDA UDIDJR FDA UDIDJC FDA UDIDKZ FDA UDIDIO FDA UDIJXM FDA UDIDIS FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3910 FDA UDI862.3870 FDA UDI862.3650 FDA UDI862.3620 FDA UDI862.3610 FDA UDI862.3100 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3150 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
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
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST Drug Test Cup 11-Panel CLIA-Waived by Jant Pharmacal Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071489 also covers:
- ACCUTEST - 5 Drug Test Cup *CLIA-Waived* — JANT PHARMACAL CORP.
- ACCUTEST - 6 Drug Cup — JANT PHARMACAL CORP.
- Status Toxi Cup — Lifesign L.L.C.
- QTEST 11 (25 pack) — MEDIMPEX UNITED, INC
- QTEST 12 (25 Pack) — MEDIMPEX UNITED, INC
- QTEST 5 (25 Pack) — MEDIMPEX UNITED, INC
- QTEST 7 (25 Pack) — MEDIMPEX UNITED, INC
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
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 U | Pending data |
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Manufacturer
- Manufacturer
- Jant Pharmacal Corp.
Sources (1)
- FDA UDI c8bbffd3-5f3e-4213-9d1d-a51b6292a041 34 fields · synced May 30, 2026