AccessGUDID - DEVICE: Autostat II Anti-B2-Glycoprotein I IgG (00816879020229)

GUDID

Device Identifier (DI) Information

Brand Name: Autostat II Anti-B2-Glycoprotein I IgG
Version or Model: FGA22
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HYCOR BIOMEDICAL LLC

Primary DI Number: 00816879020229
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 010558476 *Terms of Use

Device Description: 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgG antibodies in human serum

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e649ffde-a0be-4718-9954-eb7bdf2ddc92
Public Version Date: September 06, 2024
Public Version Number: 5
DI Record Publish Date: September 26, 2016