Catalog Number

LDL4-30

Brand Name

JAS Diagnostics

Version/Model Number

LDL4-30

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

JHM

Product Code Name

Colorimetric Method, Lipoproteins

Public Device Record Key

b2bc0e38-a9da-45fc-abc4-1a2cf0dfc741

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-