Catalog Number

20758809122

Brand Name

COBAS Acetaminophen Calibrator

Version/Model Number

20758809122

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2018

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

Yes

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

DLJ

Product Code Name

CALIBRATORS, DRUG SPECIFIC

Public Device Record Key

a3b7baa0-fe7f-4ae9-91a2-1e08ed8e77bb

Public Version Date

November 11, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-