Identity
- Trade Name
- QuikScreen FDA UDI
- Generic Name
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
- Model / Reference
- 60A41 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748349000342 FDA UDI
- FDA Product Code
- LCM FDA UDIDJG FDA UDIDJC FDA UDIDJD FDA UDIDJR FDA UDIDIO FDA UDIDIS FDA UDIDKZ FDA UDIJXN 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 UDI862.3610 FDA UDI862.3680 FDA UDI862.3620 FDA UDI862.3250 FDA UDI862.3150 FDA UDI862.3100 FDA UDI862.3700 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 by Syntron Bioresearch, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical.
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Cleared under the same submission
K071489 also covers:
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- 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.
K130275 also covers:
- Status Toxi Cup — Lifesign L.L.C.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, 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
- Syntron Bioresearch, Inc.
Sources (1)
- FDA UDI 5f8013aa-d65c-4780-a6b7-eb3f0db68a2b 33 fields · synced May 31, 2026