Etest® PLAZOMICIN - Etest is a quantitative technique for determining - BIOMERIEUX SA

Duns Number:276816717

Device Description: Etest is a quantitative technique for determining susceptibility of clinically significant Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

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More Product Details

Catalog Number

-

Brand Name

Etest® PLAZOMICIN

Version/Model Number

Etest® PLAZOMICIN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K200512,K200512

Product Code Details

Product Code

JWY

Product Code Name

Manual antimicrobial susceptibility test systems

Device Record Status

Public Device Record Key

aea42caa-bd0f-4e3d-b67b-dc935d83f40d

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 19, 2020

Additional Identifiers

Package DI Number

03573026560911

Quantity per Package

30

Contains DI Package

03573026603229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BIOMERIEUX SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 156
3 A medical device with high risk that requires premarket approval 3