N/A - Tryptic Soy Agar (TSA) (without plate label, - HARDY DIAGNOSTICS

Duns Number:039981550

Device Description: Tryptic Soy Agar (TSA) (without plate label, orientation tabs, and logo), 15x100ml Plate, Tryptic Soy Agar (TSA) (without plate label, orientation tabs, and logo), 15x100ml Plate, 23ml. Hardy Diagnostics Tryptic Soy Agar is recommended for use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance and transportation of pure cultures of microorganisms.

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More Product Details

Catalog Number

G62

Brand Name

N/A

Version/Model Number

G62

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2022

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

JSG

Product Code Name

Culture Media, Non-Selective And Non-Differential

Device Record Status

Public Device Record Key

0852c373-b6cd-4120-a15c-c5e0c038a292

Public Version Date

April 22, 2022

Public Version Number

2

DI Record Publish Date

May 20, 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