Lyme B. burgdorferi (IgM) Marstripe Test

Lyme B. burgdorferi (IgM) Marstripe Test
Immco Diagnostics, Inc. - 6101M-400

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen, using an immunoblot method.

• 400 determinations

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: 00845714004841

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