N/A - Lowenstein Jensen Medium, 20x125mm Tube, 5ml - HARDY DIAGNOSTICS

Duns Number:039981550

Device Description: Lowenstein Jensen Medium, 20x125mm Tube, 5ml Deep. Hardy Diagnostics Lowenstein Jensen Dee Lowenstein Jensen Medium, 20x125mm Tube, 5ml Deep. Hardy Diagnostics Lowenstein Jensen Deep is recommended for use in the semiquantitative catalase test to aid in differentiation of Mycobacterium species.

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More Product Details

Catalog Number

C27

Brand Name

N/A

Version/Model Number

C27

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

JSJ

Product Code Name

Culture Media, Selective And Non-Differential

Device Record Status

Public Device Record Key

c49a66e0-69e1-42ea-a9da-56f3783be5de

Public Version Date

May 21, 2020

Public Version Number

1

DI Record Publish Date

May 13, 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