N/A C27

GUDID 00819398020183

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.

HARDY DIAGNOSTICS

Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD
Primary Device ID00819398020183
NIH Device Record Keyc49a66e0-69e1-42ea-a9da-56f3783be5de
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberC27
Catalog NumberC27
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100819398020183 [Unit of Use]
GS100819398020190 [Primary]

FDA Product Code

JSJCulture Media, Selective And Non-Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

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