Catalog Number

$92068-1

Brand Name

Liofilchem MIC Test Strip (MTS)

Version/Model Number

Imipenem IMI 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

K191908,K191908,K191908

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

15f4debb-fcb6-4693-9dcc-e2e116f20f70

Public Version Date

September 24, 2019

Public Version Number

1

DI Record Publish Date

September 16, 2019

Package DI Number

28055182872293

Quantity per Package

30

Contains DI Package

08055182872299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box