CAMPY (jcl) Latex 50 Test Kit


Product Overview

CAMPY (jcl) Latex 50 Test Kit - L-CAM01T


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative detection of antigens from one or multiple species of Campylobacter bacteria isolated by culture from a clinical specimen, using an agglutination method. Species of Campylobacter bacteria detected may include C. coli, C. fetus and/or C. jejuni.


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: LQP

Device Name: Campylobacter Spp.

Device Class: 1

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: 866.3110

Third Party Flag: Y

Medical Specialty: MI


Device Identifiers

Device Id: 00813545026288

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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