Rubella IgG IFA 96 Test

Basic Information

• Brand Name: Rubella IgG IFA 96 Test
• Primary DI: G5229027001
• Version / Model: 902700
• Company Name: Hemagen Diagnostics, Inc.
• Labeler DUNS: 147827216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-05
• Public Version: 1
• Public Version Date: 2023-10-13
• Public Version Status: New
• Public Device Record Key: 372e4705-bb58-42ef-ac7a-80baa744cbef

Device Description

For the detection and titration of rubella virus IgG antibodies in human sera

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
LSD	Rubella, Other Assays	Microbiology	866.3510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50266	Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G5229027001	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K792635	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius