Histoplasma capsulatum antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Histoplasma capsulatum (H. cap.). These reagents are optimized for use in the Ouchterlony double diffusion.
Histoplasma Antigen for Fungal Immunodiffusion - 100201
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 the fungus Histoplasma capsulatum in a clinical specimen.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GMJ
Device Name: Antigens, Histoplasma Capsulatum, All
Device Class: 2
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: 866.3320
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00840733101021
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