Identity
- Trade Name
- LZI Cotinine II Level 1 Control FDA UDI
- Generic Name
- Cotinine (nicotine metabolite) IVD, control FDA UDI
- Device Name
- 5 mL/bottle. Concentration: 150 ng/mL of Cotinine. FDA UDI
- Model / Reference
- 0527 FDA UDI
- Description
- 5 mL/bottle. Concentration: 150 ng/mL of Cotinine. FDA UDI
Identifiers
- Catalog Number
- 0527 FDA UDI
- Primary DI / UDI-DI
- B07605270 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Cotinine (nicotine metabolite) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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
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, control
LZI Cotinine II Level 1 Control by Lin-Zhi International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cotinine (nicotine metabolite) IVD, control.
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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI bbc36f32-2f06-4bf1-a747-7614eeda776d 35 fields · synced Jun 9, 2026