Catalog Number

404577

Brand Name

Negative Serum Control

Version/Model Number

404577

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2018

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

BK140163

Product Code

MYP

Product Code Name

Test,Platelet Antibody

Public Device Record Key

a2593ae0-96ed-431b-8c00-8a50b84885eb

Public Version Date

August 01, 2018

Public Version Number

4

DI Record Publish Date

July 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-