Catalog Number

$92076-10

Brand Name

Liofilchem MIC Test Strip

Version/Model Number

Imipenem-relebactam I/R 0.002/4-32/4 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191809,K191809,K191809

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Public Device Record Key

694f9139-8de5-4c28-9f89-02e38f263aee

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 30, 2019

Package DI Number

18055182872487

Quantity per Package

10

Contains DI Package

08055182872480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box