Mardx Llyme Disease Eia (igg & Igm) Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K892206 FDA 510(k)
- FDA Product Code
- LSR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3830 FDA 510(k)
- Regulation Number
- 866.3830 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mardx Lyme Disease Eia (Igg & Igm) Test System is a reagent, specifically a Borrelia serological reagent, used for testing. It is classified as a device in the field of microbiology.
The test system is supplied with the specification that it is a substantially equivalent device. It has been reviewed by the Microbiology advisory committee and has a product code of LSR. The device is regulated under the regulation number 866.3830 and has been authorized with an FDA 510K clearance.
Frequently asked questions
What is the Mardx Lyme Disease EIA Test System used for?
The Mardx Lyme Disease EIA Test System is used for testing Borrelia serology, specifically for detecting IgG and IgM antibodies.
Is the Mardx Lyme Disease EIA Test System a single-use device?
The device data does not specify if the test system is for single-use or reuse, but it is supplied as a reagent for testing.
What regulatory clearance does the Mardx Lyme Disease EIA Test System have?
The Mardx Lyme Disease EIA Test System has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.
What is the product code for the Mardx Lyme Disease EIA Test System?
The product code for the Mardx Lyme Disease EIA Test System is LSR, classified under the regulation number 866.3830.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K892206 | Class II | Active |
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Manufacturer
- Manufacturer
- Mardx Diagnostics, Inc.
Sources (1)
- FDA 510(k) K892206 24 fields · synced Sep 23, 2026