Catalog Number

442967

Brand Name

BD Viper™ LT System PCR Accessory kit

Version/Model Number

442967

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

P160037

Product Code

MAQ

Product Code Name

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Public Device Record Key

00968ff6-02ba-429b-bb8f-d0815efc789a

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

February 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-