Catalog Number

04718917190

Brand Name

Cholesterol Gen.2

Version/Model Number

04718917190

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031824

Product Code

CHH

Product Code Name

ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Public Device Record Key

242b35ed-aef2-4085-8369-70bb431bf984

Public Version Date

August 13, 2021

Public Version Number

3

DI Record Publish Date

February 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-