Identity
- Trade Name
- QuikScreen 5 Drug Cup Test FDA UDI
- Generic Name
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
- Device Name
- QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50 FDA UDI
- Model / Reference
- 60505 FDA UDI
- Description
- QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748349000052 FDA UDI
- 510(k) Number
- K071489 FDA UDI
- FDA Product Code
- LCM FDA UDIDJG FDA UDIDIO FDA UDILDJ FDA UDIDKZ FDA UDI
- GMDN Term
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3250 FDA UDI862.3870 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
No
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
QuikScreen 5 Drug Cup Test by Syntron Bioresearch, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical.
- Status Toxi Cup — Lifesign L.L.C. · Class II
- QTEST 7 (25 Pack) — MEDIMPEX UNITED, INC · Class II
- QTEST 5 (25 Pack) — MEDIMPEX UNITED, INC · Class II
- QTEST 12 (25 Pack) — MEDIMPEX UNITED, INC · Class II
- QTEST 11 (25 pack) — MEDIMPEX UNITED, INC · Class II
- QuikScreen — SYNTRON BIORESEARCH, INC. · Class II
- QuikStrip Multidrug Screening Dip Card Test — SYNTRON BIORESEARCH, INC. · Class II
- QuikStrip MultiDrug 4 Dip Card Test — SYNTRON BIORESEARCH, INC. · Class II
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.
- ACCUTEST Drug Test Cup 11-Panel CLIA-Waived — 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.
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
- Syntron Bioresearch, Inc.
Sources (1)
- FDA UDI 1e6efa61-2df7-459a-9cf9-50acb27183ca 34 fields · synced Jun 8, 2026