Catalog Number

10376501

Brand Name

ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent

Version/Model Number

10376501

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K923504,K923504

Product Code

CHH

Product Code Name

ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Public Device Record Key

62e05b7d-3fc8-4aa6-a578-d52e407e6771

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-