Identity
- Trade Name
- Cotinine ELISA FDA UDI
- Generic Name
- Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Cotinine ELISA Kit is intended for the measurement of Cotinine in serum, urine. FDA UDI
- Model / Reference
- EIA-5917 FDA UDI
- Description
- The Cotinine ELISA Kit is intended for the measurement of Cotinine in serum, urine. FDA UDI
Identifiers
- Catalog Number
- EIA-5917 FDA UDI
- Primary DI / UDI-DI
- 00840239059178 FDA UDI
- FDA Product Code
- MRS 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
Yes
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
Yes
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 ELISA by DRG International, 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).
- Kit, MP Cotinine Serum 100 plate — OraSure Technologies, Inc. · Class I
- Cotinine (COT) Rapid Test Dipstick — Hangzhou AllTest Biotech Co., Ltd. · Class I
- AccuSign® Nicotine card — PRINCETON BIOMEDITECH CORP. · Class I
- Cotinine OraSure 100 Plate Kit — OraSure Technologies, Inc. · Class I
- Status™ Nicotine card — PRINCETON BIOMEDITECH CORP. · Class I
- Auto-Lyte — OraSure Technologies, Inc. · Class I
- Salimetrics — SALIMETRICS LLC. · Class I
- Accutest NicAlert Saliva Cotinine Test — JANT PHARMACAL CORP. · Class I
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
- DRG International, Inc.
Sources (1)
- FDA UDI 5760b732-05ed-46ee-bf54-b44b606d0eb2 36 fields · synced May 30, 2026