Identity
- Trade Name
- Auto-Lyte FDA UDI
- Generic Name
- Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Auto-Lyte Cotinine Urine 100mL FDA UDI
- Model / Reference
- 1224UL FDA UDI
- Description
- Auto-Lyte Cotinine Urine 100mL FDA UDI
Identifiers
- Catalog Number
- 1224UL FDA UDI
- Primary DI / UDI-DI
- 00608337000474 FDA UDI
- 510(k) Number
- K972481 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)
Auto-Lyte 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
K972481 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (1)
- FDA UDI d00ed169-a3c8-4b17-990e-8b6cfc58fd41 36 fields · synced Jun 9, 2026