IMMY

Basic Information

• Brand Name: IMMY
• Primary DI: 00816387020759
• Version / Model: CRY101
• Company Name: Immuno-Mycologics, Inc.
• Labeler DUNS: 099550915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2022-03-28
• Public Version Status: Update
• Public Device Record Key: 194d0373-0a70-4dae-ab4d-73408f62d15d

Device Description

Cryptococcus Antigen EIA

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
MDU	Antigen, Elisa, Cryptococcus	Microbiology	866.3165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52072	Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the yeast Cryptococcus neoformans in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816387020759	GS1
Unit of Use	00816387020766	GS1

Customer Contacts

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