Identity
- Trade Name
- LZI Cotinine II Enzyme Immunoassay FDA UDI
- Generic Name
- Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL. FDA UDI
- Model / Reference
- 0520 FDA UDI
- Description
- Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL. FDA UDI
Identifiers
- Catalog Number
- 0520 FDA UDI
- Primary DI / UDI-DI
- B07605200 FDA UDI
- 510(k) Number
- K192299 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)
LZI Cotinine II Enzyme Immunoassay by Lin-Zhi International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA).
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- Cotinine OraSure 100 Plate Kit — OraSure Technologies, Inc. · Class I
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- Salimetrics — SALIMETRICS LLC. · Class I
Cleared under the same submission
K192299 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 |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 0e87559c-fb25-45c2-a740-ec481ef4b32f 36 fields · synced Jun 9, 2026