Ehrlichia chaffeensis 12wl; 10 pk


Product Overview

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 Identifiers

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


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