Catalog Number

920640

Brand Name

Liofilchem MTS (MIC Test Strip)

Version/Model Number

Lefamulin LMU 0.016-256 100 MTS canister

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

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

0a701c04-eeef-40ea-9ea5-5fe6346198f3

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-