Ehrlichia chaffeensis 12wl; 10 pk

Ehrlichia chaffeensis 12wl; 10 pk - I-ECH01X

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Ehrlichia chaffeensis in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Ehrlichia chaffeensis, the rickettsial bacteria associated with human monocytic ehrlichiosis (HME).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LSQ

Device Name: Reagent, Rickettsia Serological

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 866.3500

Third Party Flag: N

Medical Specialty: MI

Device Id: 00813545025649

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