Catalog Number

5152A

Brand Name

Immco Diagnostics, Inc

Version/Model Number

5152A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

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)

Yes

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

a83276c5-a779-4676-b82e-22d1d6d955b0

Public Version Date

August 16, 2022

Public Version Number

3

DI Record Publish Date

July 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-