ETEST® Piperacillin/Tazobactam - 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® Piperacillin/Tazobactam

Version/Model Number

ETEST® Piperacillin/Tazobactam

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

K190154,K190154

Product Code Details

Product Code

JWY

Product Code Name

Manual antimicrobial susceptibility test systems

Device Record Status

Public Device Record Key

f87c025d-7fef-43c7-bb08-3bb2d25b5152

Public Version Date

May 29, 2019

Public Version Number

1

DI Record Publish Date

May 21, 2019

Additional Identifiers

Package DI Number

03573026555832

Quantity per Package

30

Contains DI Package

03573026563509

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