Immunalysis Cannabinoids Urine Enzyme Immunoassay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151203 FDA 510(k)
- FDA Product Code
- LDJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3870 FDA 510(k)
- Regulation Number
- 862.3870 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Immunalysis Cannabinoids Urine Enzyme Immunoassay is an enzyme immunoassay for the qualitative and semi-quantitative analysis of Cannabinoids in human urine. It is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL, intended for use in laboratories with automated clinical chemistry analyzers.
The device is supplied with associated calibrators and control set, and is marketed under general controls, having been determined by the FDA to be substantially equivalent to legally marketed predicate devices. The device has a product code of LDJ and regulation number 862.3870.
Frequently asked questions
What is the Immunalysis Cannabinoids Urine Enzyme Immunoassay used for?
The Immunalysis Cannabinoids Urine Enzyme Immunoassay is used for the qualitative and semi-quantitative analysis of Cannabinoids in human urine.
What is the cutoff value for this assay?
The cutoff value for the Immunalysis Cannabinoids Urine Enzyme Immunoassay is 50ng/mL.
Is the device supplied with calibrators and control set?
Yes, the Immunalysis Cannabinoids Urine Enzyme Immunoassay is supplied with associated calibrators and control set.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC ..., Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis Cthc ..., Immunalysis CTHC Urine Control Set | PDF | Elisa | Immunoassay - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151203 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA 510(k) K151203 24 fields · synced Sep 22, 2026