For the detection of circulating antibody to common systemic pathogens.
Fungal Immunodiffusion Plates - 4 Series - 101009
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple exoantigens from fungal species, which may include Histoplasma capsulatum, Blastomyces dermatitidis and/or Coccidioides immitis in a clinical specimen, using a precipitation/immunodiffusion method.
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: JZQ
Device Name: Plates And Equipment, Radial Immunodiffusion
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: IM
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: 866.4800
Third Party Flag: N
Medical Specialty: IM
Device Identifiers
Device Id: 00840733101397
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
