Catalog Number

210543

Brand Name

Neg Control

Version/Model Number

210543

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)

Yes

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

BK160084,BK160084

Product Code

KSF

Product Code Name

Kit, Quality Control For Blood Banking Reagents

Public Device Record Key

b7aee317-a3fe-4317-b1b2-dd8357b7225d

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

May 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-