Immunalysis Opiates Elisa For Oral Fluids
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051626 FDA 510(k)
- FDA Product Code
- DJG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Immunalysis Opiates ELISA for Oral Fluids is an enzyme immunoassay test system designed for the qualitative detection of opiates in oral fluid samples. It provides a preliminary analytical test result that requires a more specific alternate chemical method for confirmation.
This device is categorized under clinical toxicology and is authorized via FDA 510(k) clearance under regulation number 862.3650. It is manufactured by Immunalysis Corporation and is identified by product code DJG.
Frequently asked questions
What is the primary purpose of the Immunalysis Opiates ELISA?
This device is designed for the qualitative detection of opiates within oral fluid samples. It serves as a preliminary analytical test system within the field of clinical toxicology.
Does this test provide a final confirmation of opiates?
No, this device provides only a preliminary analytical test result. Because it is a screening tool, any positive result requires the use of a more specific alternate chemical method to confirm the presence of opiates.
What is the regulatory status of this device?
The Immunalysis Opiates ELISA for Oral Fluids is authorized via FDA 510(k) clearance. It is categorized under regulation number 862.3650 and identified by product code DJG.
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 OPIATES ELISA FOR ORAL FLUIDS (K051626) — FDA 510(k ..., IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS 510(k) K051626 - fda.report, fda.innolitics.com, IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS 510(k) K051626 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051626 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA 510(k) K051626 24 fields · synced Sep 26, 2026