Identity
- Trade Name
- QTEST 11 (25 pack) FDA UDI
- Generic Name
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
- Device Name
- Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50 FDA UDI
- Model / Reference
- DOA-11Ca FDA UDI
- Description
- Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10864040000331 FDA UDI
- 510(k) Number
- K071489 FDA UDI
- FDA Product Code
- LFH FDA UDILCM FDA UDIDJG FDA UDIDJR FDA UDIDJC FDA UDIDIO FDA UDILDJ FDA UDIJXM FDA UDIDIS FDA UDIDKZ FDA UDI
- GMDN Term
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3910 FDA UDI862.3650 FDA UDI862.3620 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3170 FDA UDI862.3150 FDA UDI862.3100 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: Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QTEST 11 (25 pack) by Medimpex United, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071489 also covers:
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- ACCUTEST - 6 Drug Cup — JANT PHARMACAL CORP.
- ACCUTEST Drug Test Cup 11-Panel CLIA-Waived — JANT PHARMACAL CORP.
- Status Toxi Cup — Lifesign L.L.C.
- 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 II | Pending data |
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Manufacturer
- Manufacturer
- Medimpex United, Inc
Sources (1)
- FDA UDI 986635bd-41ee-4b5e-a129-5af0ee1cf4b4 34 fields · synced Jun 7, 2026