Ehrlichia chaffeensis 12wl; 10 pk - I-ECH01X
Device Description
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).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice 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