Catalog Number

P080016

Brand Name

Pro Advantage

Version/Model Number

P080016

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KTN

Product Code Name

System, Test, Infectious Mononucleosis

Public Device Record Key

b33b28ca-2064-461f-92a0-7204a6f0f671

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

M220P0800165

Quantity per Package

10

Contains DI Package

M220P0800163

Package Discontinue Date

-

Package Status

-

Package Type

case