Catalog Number

00024001811

Brand Name

GEM CVP (Calibration Validation Product) Level 1

Version/Model Number

00024001811

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

K052121,K052121

Product Code

JJY

Product Code Name

Multi-analyte controls, all kinds (assayed)

Public Device Record Key

ca8db343-9f29-4ba8-9cb7-5c529ee4d443

Public Version Date

July 13, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-