Catalog Number

03-2140-01

Brand Name

INFINITI® Warfarin Intellipac® Reagent Module

Version/Model Number

03-2140-01

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

K073014

Product Code

ODV

Product Code Name

Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system

Public Device Record Key

a8379e16-e607-44cd-a791-05c0405dd4da

Public Version Date

October 31, 2019

Public Version Number

1

DI Record Publish Date

October 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-