Catalog Number

-

Brand Name

ABX PENTRA CHOLESTEROL CP

Version/Model Number

1220001634

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K060854

Product Code

CHH

Product Code Name

Enzymatic Esterase--Oxidase, Cholesterol

Public Device Record Key

4cf3279c-3e2e-4531-9b4b-451cb95c289d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-