Catalog Number

303673

Brand Name

PRODESSE

Version/Model Number

PROFAST+ KIT, 100 REACTIONS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132237

Product Code

OOI

Product Code Name

real time Nucleic acid amplification system

Public Device Record Key

3b71d8d8-9d1a-4157-a912-16460f141ae4

Public Version Date

October 15, 2020

Public Version Number

4

DI Record Publish Date

April 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-