Catalog Number

-

Brand Name

Fast 96-Well Region of Interest (ROI) and Background Plates

Version/Model Number

4432638

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

K123955

Product Code

OOI

Product Code Name

real time Nucleic acid amplification system

Public Device Record Key

4b1032ff-df6b-41df-bfe9-610c3875c0f5

Public Version Date

June 18, 2019

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-