Catalog Number

643438

Brand Name

N/A

Version/Model Number

643438

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK050073

Product Code

MZI

Product Code Name

Test, qualitative, for HLA, non-diagnostic

Public Device Record Key

6df1cb22-b259-49b7-a405-6802b66567e7

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

January 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-