Catalog Number

997-72591

Brand Name

L-Type HDL-C Reagent 1

Version/Model Number

997-72591

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2020

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

K963847,K963847

Product Code

LBR

Product Code Name

Ldl & Vldl Precipitation, Hdl

Public Device Record Key

184f9652-784e-4c65-922a-7c7343c2150d

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

November 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-