Catalog Number

-

Brand Name

Autostat II Anti-B2-Glycoprotein I IgM

Version/Model Number

FGA23

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K022944

Product Code

MSV

Product Code Name

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

Public Device Record Key

68d4d410-d710-47eb-b5de-8e6d814e472a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-