Identity
- Trade Name
- AIMSTEP COTININE FDA UDI
- Generic Name
- Cotinine (nicotine metabolite) IVD, reagent FDA UDI
- Device Name
- Cassette test for nicotine FDA UDI
- Model / Reference
- 40015 FDA UDI
- Description
- Cassette test for nicotine FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684400156 FDA UDI
- FDA Product Code
- MRS FDA UDI
- GMDN Term
- Cotinine (nicotine metabolite) IVD, reagent 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
No
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, reagent
Aimstep Cotinine by Germaine Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cotinine (nicotine metabolite) IVD, reagent.
- Nano-CheckTM Nicotine 500 — Nano-Ditech Corporation · Class I
- FIRSTVIEW COT Urine Dip card Test — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Nano-CheckTM Nicotine — Nano-Ditech Corporation · Class I
- AIMSTEP COTININE — GERMAINE LABORATORIES, INC. · Class I
- AIMSTEP COTININE — GERMAINE LABORATORIES, INC. · 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
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI c9fed968-4eb7-4ea4-8990-e84272259021 33 fields · synced Jun 7, 2026