Pathfinder Chlamydia Culture Confirmation System
Pathfinder - 30701
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Chlamydia trachomatis bacteria in a clinical specimen.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- 100 Tests
- Total Volume: 4.2 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LJP
Device Name: Antiserum, Fluorescent, Chlamydia Trachomatis
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: 866.3120
Third Party Flag: Y
Medical Specialty: MI
Device IdentifiersDevice Id: 00847865001427
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