Catalog Number

-

Brand Name

MicroScan

Version/Model Number

V4.42

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

-

Product Code

LON

Product Code Name

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Public Device Record Key

f3019f5f-3c54-4635-87f2-f0e77d5d7bd6

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

15099590677831

Quantity per Package

1

Contains DI Package

15099590676889

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

6000-0060