Catalog Number

-

Brand Name

MicroScan

Version/Model Number

B1017-425

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

K010418,K032706,K050585,K061536,K083262,K101425,K862140,K863776,K870074,K874876,K883076,K926545,K941030,K955910,K962150,K970676,K971376,K981199,K010418,K981199,K971376,K970676,K962150,K955910,K941030,K926545,K883076,K874876,K870074,K863776,K862140,K101425,K083262,K061536,K050585,K032706

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

fc4e55dd-0e6d-4e86-8d76-f440e6a860de

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-