Catalog Number

$92027-10

Brand Name

Liofilchem Mic Test Strip (MTS)

Version/Model Number

Ampicillin*-sulbactam (2/1) AMS 0.016-256*

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)

Yes

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

K192345,K192345,K192345

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

3cbbc222-8eb8-4257-b0b5-a15ad2311f1f

Public Version Date

December 16, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2019

Package DI Number

18055182871169

Quantity per Package

10

Contains DI Package

08055182871162

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX