Catalog Number

$92064-1

Brand Name

Liofilchem MTS (MIC Test Strip)

Version/Model Number

Lefamulin LMU 0.016-256 µg/ml, 1 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

K200308,K200308,K200308

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

821f3593-9b6b-4606-b2a6-677b81d00c1f

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 15, 2020

Package DI Number

18055182872173

Quantity per Package

10

Contains DI Package

08055182872176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box