AccessGUDID - DEVICE: Anti-Beta 2 Glycoprotein Screen ELISA (B24235B2SHUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-Beta 2 Glycoprotein Screen ELISA
Version or Model: 35-B2SHU-E01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 35-B2SHU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24235B2SHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date: August 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Beta-2glycoprotein I highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against Beta-2-glycoprotein I 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):	Yes
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 [?]
K062217	000

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: 2a35efec-4f83-490a-9851-873767e7d1d5
Public Version Date: September 20, 2022
Public Version Number: 4
DI Record Publish Date: August 28, 2017