IMMY

Basic Information

• Brand Name: IMMY
• Primary DI: 00816387020810
• Version / Model: CL1001
• Company Name: Immuno-Mycologics, Inc.
• Labeler DUNS: 099550915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 80
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: b2f46a60-112e-44ca-a547-ea9ded46d8b5

Device Description

Latex Agglutination - Coccidioides Antibody System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
GMG	Antigen, Latex Agglutination, Coccidioides Immitis	Microbiology	866.3135	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52080	Coccidioides immitis total antibody IVD, kit, rapid agglutination, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to the fungus Coccidioides immitis in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816387020810	GS1
Unit of Use	00816387020612	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K791381	000