Catalog Number

6000-0071

Brand Name

MicroScan

Version/Model Number

V4.42MUA

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

-

Product Code

LON

Product Code Name

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Public Device Record Key

3700b52d-5123-4ab5-819d-39b0c5d0bca8

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

November 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-