Catalog Number

88769

Brand Name

Alere Cholestech LDX®

Version/Model Number

88769

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JGY

Product Code Name

Colorimetric Method, Triglycerides

Public Device Record Key

973dfba9-91b8-4a83-b555-f66a546c3ebe

Public Version Date

April 30, 2018

Public Version Number

1

DI Record Publish Date

March 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-