Catalog Number

$92071-10

Brand Name

Liofilchem Mic Test Strip (MTS)

Version/Model Number

Omadacycline 0.002-32 µg/mL, 10 Strip

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

77b4131b-0f05-4b8b-b938-b74578d693c1

Public Version Date

April 01, 2020

Public Version Number

2

DI Record Publish Date

January 31, 2019

Package DI Number

18055182872395

Quantity per Package

10

Contains DI Package

08055182872398

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box