Directigen 1-2-3 Infectious Mononucleosis Controls
FDA 510(k)Class II (US FDA 510(k))
by Quidel Corp.
Identifiers
- 510(k) Number
- K896926 FDA 510(k)
- FDA Product Code
- KTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5640 FDA 510(k)
- Regulation Number
- 866.5640 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Directigen 1-2-3 Infectious Mononucleosis Controls are components of an infectious mononucleosis immunological test system. This system consists of reagents used to measure heterophile antibodies associated with infectious mononucleosis in serum, plasma, and other body fluids through immunochemical techniques.
These controls are supplied for use in clinical settings and have received FDA 510(k) clearance. The device is classified under regulation number 866.5640 within the immunology medical specialty.
Frequently asked questions
What is the purpose of the Directigen 1-2-3 Infectious Mononucleosis Controls?
These controls are designed as components of an immunological test system. They are used to measure heterophile antibodies associated with infectious mononucleosis in patient samples, including serum, plasma, and other body fluids.
In what environment should these controls be used?
These controls are intended for use in clinical settings where infectious mononucleosis testing is performed using immunochemical techniques.
What is the regulatory status of this device?
The Directigen 1-2-3 Infectious Mononucleosis Controls have received FDA 510(k) clearance. The device is classified under regulation number 866.5640 within the immunology medical specialty.
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: Directigen 1-2-3 Infectious Mononucleosis Test, DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST 510(k) K893737 - fda.report, PDF K896926 - Directigen 1-2-3 Infectious Mononucleosis Controls, 510(k) K896926 — DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896926 | Class II | Active |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA 510(k) K896926 24 fields · synced Sep 22, 2026