IMMY

Basic Information

• Brand Name: IMMY
• Primary DI: 00816387020599
• Version / Model: QDXH70
• Company Name: Immuno-Mycologics, Inc.
• Labeler DUNS: 099550915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-03-28
• Public Version Status: Update
• Public Device Record Key: 0350bd88-7b4a-4311-8085-198a76bfa824

Device Description

Histoplasma Mycelial CF Antigen

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
52093	Histoplasma capsulatum total antibody IVD, kit, complement fixation test (CFT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the fungus Histoplasma capsulatum in a clinical specimen, using a complement fixation test (CFT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816387020599	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K791384	000