Catalog Number

-

Brand Name

ALBAcheck BGS Reagent Control for Anti-D

Version/Model Number

Z271U

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 2020

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

-

Product Code

KSF

Product Code Name

Kit, Quality Control For Blood Banking Reagents

Public Device Record Key

f4f42f2a-bc15-441a-a385-440b7693f739

Public Version Date

March 31, 2022

Public Version Number

9

DI Record Publish Date

November 28, 2014

Package DI Number

05060242471070

Quantity per Package

10

Contains DI Package

05060242471513

Package Discontinue Date

June 18, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton