Identity
- Trade Name
- Cannabinoid Enzyme Immunoassay FDA UDI
- Generic Name
- Cannabinoid/cannabinoid 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
- 0070c FDA UDI
- Description
- Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL. FDA UDI
Identifiers
- Catalog Number
- 0070c FDA UDI
- Primary DI / UDI-DI
- B0760070C0 FDA UDI
- 510(k) Number
- K110239 FDA UDI
- FDA Product Code
- LDJ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 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: Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Cannabinoid Enzyme Immunoassay by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110239 also covers:
- Cannabinoid Enzyme Immunoassay — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Negative Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator/Control, Calibrator/Control — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator/Control, Calibrator/Control — Lin-Zhi International, Inc.
- Cannabinoids DAU Control, Control — Lin-Zhi International, Inc.
- Cannabinoids DAU Control, Control — Lin-Zhi International, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 4cb3588a-b07e-404b-b65a-96805373d8dc 36 fields · synced Jun 9, 2026