DSG 1 & DSG 3 ELISA TEST

Basic Information

• Brand Name: DSG 1 & DSG 3 ELISA TEST
• Primary DI: B110RGM7593D0
• Version / Model: RG-M7593-D
• Catalog Number: RG-M7593-D
• Company Name: Bion Enterprises, Ltd.
• Labeler DUNS: 024824641
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 5
• Public Version Date: 2020-07-15
• Public Version Status: Update
• Public Device Record Key: 4d4f63a0-073e-4407-93fb-69aa20b76a8b
• Distribution End Date: 2020-07-13

Device Characteristics

• Single Use: No
• 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
NBO	Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62293	Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody 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 antibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of the autoimmune pemphigus skin diseases pemphigus foliaceus and pemphigus vulgaris.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B110RGM7593D0	HIBCC

Customer Contacts

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

Storage Conditions

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