Identity
- Trade Name
- AccuSign® Nicotine card FDA UDI
- Generic Name
- Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuSign® Nicotine card; 35 Test Kit FDA UDI
- Model / Reference
- DOA-217-35-00 FDA UDI
- Description
- AccuSign® Nicotine card; 35 Test Kit FDA UDI
Identifiers
- Catalog Number
- DOA-217-35-00 FDA UDI
- Primary DI / UDI-DI
- 10743816000235 FDA UDI
- 510(k) Number
- K062565 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
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
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)
AccuSign® Nicotine card by Princeton Biomeditech Corp. — 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 ELISA — DRG International, Inc. · Class I
- Cotinine (COT) Rapid Test Dipstick — Hangzhou AllTest Biotech Co., Ltd. · Class I
- Cotinine OraSure 100 Plate Kit — OraSure Technologies, Inc. · Class I
- Auto-Lyte — OraSure Technologies, Inc. · 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
Cleared under the same submission
K062565 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
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 10c1f746-f27c-4f4f-b7ab-6090322468bb 37 fields · synced May 30, 2026