Catalog Number

FBGP200

Brand Name

DIASTAT anti-B2 Glycoprotein-1 IgG

Version/Model Number

FBGP200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MSV

Product Code Name

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Public Device Record Key

79b81eff-ced5-4fec-b37d-e0e72c83a789

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-