Catalog Number

$92156-10

Brand Name

Liofilchem MIC Test Strip

Version/Model Number

Doxycycline DXT 0.016-256

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

K190914,K190914,K190914

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

dfb9b0f6-232a-419b-97d1-64da3eab0b3e

Public Version Date

September 20, 2019

Public Version Number

1

DI Record Publish Date

September 12, 2019

Package DI Number

18055182873835

Quantity per Package

10

Contains DI Package

08055182873838

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box