Identity
- Trade Name
- Cotinine Serum 2 Plate Kit FDA UDI
- Generic Name
- Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 1124ET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00608337000405 FDA UDI
- 510(k) Number
- K974534 FDA UDI
- FDA Product Code
- MKU FDA UDI
- GMDN Term
- Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Cotinine Serum 2 Plate Kit by OraSure Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA).
- Cotinine ELISA — DRG International, Inc. · Class I
- Cotinine (COT) Rapid Test Dipstick — Hangzhou AllTest Biotech Co., Ltd. · Class I
- AccuSign® Nicotine card — PRINCETON BIOMEDITECH CORP. · Class I
- Status™ Nicotine card — PRINCETON BIOMEDITECH CORP. · Class I
- Salimetrics — SALIMETRICS LLC. · Class I
- Accutest NicAlert Saliva Cotinine Test — JANT PHARMACAL CORP. · Class I
- Cotinine ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- LZI Cotinine II Enzyme Immunoassay — Lin-Zhi International, Inc. · Class I
Cleared under the same submission
K974534 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (1)
- FDA UDI 3d4a1981-c0d6-431e-acd9-1b8f1516f7ce 35 fields · synced Jun 9, 2026