Catalog Number

04618955001

Brand Name

Factor II Prothrombin G20210A Kit

Version/Model Number

1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NPR

Product Code Name

TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR

Public Device Record Key

8e7b6552-2492-4a33-b175-994ccf117ba4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-