Catalog Number

0895

Brand Name

Multi-Analyte DAU Calibrator Set E, High Calibrator

Version/Model Number

0895

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DKB

Product Code Name

Calibrators, Drug Mixture

Public Device Record Key

59cec0f8-f009-455a-a9bd-8b1906d869dc

Public Version Date

April 03, 2019

Public Version Number

1

DI Record Publish Date

March 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-