Fungal Serology

Basic Information

• Brand Name: Fungal Serology
• Primary DI: 10634853000091
• Version / Model: 200120
• Catalog Number: 200120
• Company Name: MICROBIOLOGICS INC.
• Labeler DUNS: 060467826
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 5
• Public Version Date: 2024-02-09
• Public Version Status: Update
• Public Device Record Key: 6145a5f5-6bf2-480b-bb06-3ca5491b451a
• Distribution End Date: 2023-11-30

Device Description

Histoplasma capsulatum Antigen (H&M), 1mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GMJ	Antigens, Histoplasma Capsulatum, All	Microbiology	866.3320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52087	Histoplasma capsulatum antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from the fungus Histoplasma capsulatum in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10634853000091	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – -20 Degrees Celsius