VIDAS Lyme IgM II assay is an automated qualitative enzyme immunoassay intended for use on VIDAS family instrument for detection of human IgM antibodies to Borrelia burgdorferi.

VIDAS Lyme IgM II assay is an automated qualitative enzyme immunoassay intended for use on VIDAS family instrument for detection of human IgM antibodies to Borrelia burgdorferi.
VIDAS® Lyme IgM II - 416436

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LSR

Device Name: Reagent, Borrelia Serological Reagent

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3830

Third Party Flag: N

Medical Specialty: MI

Device Id: 03573026447151

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A