Autostat II Anti-B2-Glycoprotein I IgM

Basic Information

• Brand Name: Autostat II Anti-B2-Glycoprotein I IgM
• Primary DI: 00816879020236
• Version / Model: FGA23
• Company Name: HYCOR BIOMEDICAL LLC
• Labeler DUNS: 010558476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 68d4d410-d710-47eb-b5de-8e6d814e472a

Device Description

96 well ELISA for the detection of Anti-B2-Glycoprotein I IgM antibodies in human serum

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: Yes
• 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
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54879	Beta-2-glycoprotein I 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 one or multiple classes of antibodies to beta-2-glycoprotein I 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	00816879020236	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K022944	000

Storage Conditions

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