iFlash-Anti-Beta2-Glycoprotein I

Basic Information

• Brand Name: iFlash-Anti-Beta2-Glycoprotein I
• Primary DI: 06925912717836
• Version / Model: C89027Z
• Company Name: Shenzhen YHLO Biotech Co., Ltd.
• Labeler DUNS: 420735989
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-26
• Public Version: 1
• Public Version Date: 2022-11-03
• Public Version Status: New
• Public Device Record Key: 4962da24-8544-461d-9fb9-6413cffcea9f

Device Description

"Beta" is identical to the second letter of Greek alphabet. Because GUDID system couldn't recognize this letter, it is replaced by "Beta". The acutal product name would be showed with the second letter of Greek alphabet instead of "Beta".

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DDN	Beta-2-Glycoprotein I, Antigen, Antiserum, Control	Immunology	866.5430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60496	Beta-2-glycoprotein I antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to beta-2-glycoprotein I in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06925912717836	GS1