Catalog Number

991-00101

Brand Name

L-Type HDL-C Reagent 1

Version/Model Number

991-00101

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

K963847,K963847,K963847

Product Code

JIS

Product Code Name

Calibrator, Primary

Public Device Record Key

ab4608c8-77b9-4839-80fd-6287fabc4784

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

October 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-