Catalog Number

$92009-10

Brand Name

Liofilchem MIC Test Strip

Version/Model Number

Gentamicin 0.016-256 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190252,K190252,K190252

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

e45d4449-d3c1-4848-82e7-276fc6cd17c7

Public Version Date

August 12, 2019

Public Version Number

1

DI Record Publish Date

August 02, 2019

Package DI Number

18055182870629

Quantity per Package

10

Contains DI Package

08055182870622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box