Catalog Number

HDL4-250

Brand Name

JAS Diagnostics

Version/Model Number

HDL4-250

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

K021671

Product Code

LBS

Product Code Name

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Public Device Record Key

158efa40-3d54-486e-94d3-bf711467a10a

Public Version Date

December 07, 2018

Public Version Number

5

DI Record Publish Date

October 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-