ETEST® - ETEST® is a manual, quantitative technique for - BIOMERIEUX SA

Duns Number:276816717

Device Description: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibili ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria

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More Product Details

Catalog Number

-

Brand Name

ETEST®

Version/Model Number

ETEST®

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

K961519,K961519,K961519

Product Code Details

Product Code

JWY

Product Code Name

Manual antimicrobial susceptibility test systems

Device Record Status

Public Device Record Key

24fda99c-535e-4af0-b6bd-910be56ad7dd

Public Version Date

July 21, 2021

Public Version Number

1

DI Record Publish Date

July 13, 2021

Additional Identifiers

Package DI Number

03573026618803

Quantity per Package

10

Contains DI Package

03573026620035

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