Catalog Number

20763063122

Brand Name

no MS ISE Calibrator IndirectUrine)

Version/Model Number

20763063122

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

K963627

Product Code

JIX

Product Code Name

CALIBRATOR, MULTI-ANALYTE MIXTURE

Public Device Record Key

f5d3e907-2066-4dab-8f22-a2103d7d4bc1

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-