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 IdentifiersDevice 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