Catalog Number

-

Brand Name

Anti-Human Ki-67 FITC Conjugate

Version/Model Number

MHKI6701

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

-

Product Code

MVU

Product Code Name

Reagents, specific, analyte

Public Device Record Key

be1dc6d5-083b-4a39-af1b-4c0de11ec7e7

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-