Catalog Number

10-986

Brand Name

Alere Cholestech LDX®

Version/Model Number

10-986

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

-

Product Code

CHH

Product Code Name

Enzymatic Esterase--Oxidase, Cholesterol

Public Device Record Key

5b4b2904-524f-420e-917f-5d71731809ad

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-