Catalog Number

03502295001

Brand Name

High Pure System Viral Nucleic Acid Kit

Version/Model Number

03502295001

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

-

Product Code

MKT

Product Code Name

Hepatitis Viral B DNA Detection

Public Device Record Key

39bfa0eb-cf45-43b9-84ce-5e13d273d58b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 10, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-