N/A - Urine Quad Plate (EMB/Modified XLD/Simmons - HARDY DIAGNOSTICS

Duns Number:039981550

Device Description: Urine Quad Plate (EMB/Modified XLD/Simmons Citrate/Blood Agar, 5%), 15x100mm Plate, 20ml. Urine Quad Plate (EMB/Modified XLD/Simmons Citrate/Blood Agar, 5%), 15x100mm Plate, 20ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. Hardy Diagnostics Simmons Citrate Agar is recommended for use in the differentiation of gram-negative enteric bacilli based on citrate utilization. Hardy Diagnostics XLD Agar with Novobiocin is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens from foods or other samples. Modified XLD Agar is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens from specimens.

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More Product Details

Catalog Number

J71

Brand Name

N/A

Version/Model Number

J71

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JSH

Product Code Name

Culture Media, Non-Selective And Differential

Device Record Status

Public Device Record Key

f3bb4371-979b-4e4f-9082-ace6c6db3cc6

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARDY DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 630
2 A medical device with a moderate to high risk that requires special controls. 132