Catalog Number

-

Brand Name

Human CD19 R-PE Conjugate

Version/Model Number

MHCD1904

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 27, 2022

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

K963954

Product Code

GKZ

Product Code Name

Counter, differential cell

Public Device Record Key

f63590b2-7ace-42a1-a7a3-548f61c35390

Public Version Date

May 12, 2022

Public Version Number

6

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-