Catalog Number

4526346

Brand Name

artus® HSV-1/2 QS-RGQ MDx Kit

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 04, 2017

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

OQO

Product Code Name

Herpes Simplex Virus Nucleic Acid Amplification Assay

Public Device Record Key

3d09d998-2169-4f53-91af-72091e6236dc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-