Catalog Number

990-28011

Brand Name

HDL-C/LDL-C Calibrator

Version/Model Number

990-28011

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

K001005,K001005,K001005

Product Code

JIS

Product Code Name

Calibrator, Primary

Public Device Record Key

d53325df-9aa3-4dd7-8eab-59f5fc6a54dc

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

October 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-