Catalog Number

404578

Brand Name

Normal Platelet Control (Negative Eluate Control)

Version/Model Number

404578

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

BK960059

Product Code

MYP

Product Code Name

Test,Platelet Antibody

Public Device Record Key

9456bc47-6529-4bc8-bfaa-6cc4f2572624

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-