Catalog Number

4J94-23

Brand Name

ViroSeq

Version/Model Number

4J94-23

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

BK130039

Product Code

NHS

Product Code Name

Assay, genotype, hiv drug resistance, in vitro

Public Device Record Key

9ce3c0de-661f-4109-a64a-3abedb386815

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

January 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-