N/A C21

GUDID 00819398020121

Lowenstein Jensen, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.

HARDY DIAGNOSTICS

Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD
Primary Device ID00819398020121
NIH Device Record Key26a40618-b120-4e33-8ddd-6389aaff80bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberC21
Catalog NumberC21
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100819398020121 [Unit of Use]
GS100819398020121 [Unit of Use]
GS100819398020121 [Unit of Use]
GS100819398020138 [Primary]
GS100819398020138 [Primary]
GS100819398020138 [Primary]

FDA Product Code

JSJCulture Media, Selective And Non-Differential
JSJCulture Media, Selective And Non-Differential
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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00816576023868Horse Blood Agar 5%, 15x100mm Plate, 17ml. Hardy Diagnostics Horse Blood Agar is an enriched al
00816576023820Campylobacter Blood Agar, 15x100mm plate, 18ml. Hardy Diagnostics Campylobacter Blood Agar is r
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00816576023783Campy Cefex Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics Campy Cefex Agar, Modified p
00816576023769Blood Agar with Ampicillin, 15x100mm Plate, 17ml. Hardy Diagnostics Blood Agar with Ampicillin i
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00819398023917LJ with Iron, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended f
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00819398020367Trichophyton Agar #2, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers
00819398020343Trichophyton Agar #1, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers
00819398020329Middlebrook 7H10 with Human Blood, 10ml Slant. Hardy Diagnostics Middlebrook 7H10 Agar with Hum
00819398020268Middlebrook 7H10 Agar, 20x125mm Tube, 10ml Slant. Hardy Diagnostics Middlebrook 7H10 Agar is re
00819398020244Middlebrook 7H9 Broth, 16x125mm Tube, 10ml. Hardy Diagnostics Middlebrook 7H9 Broth and Middleb
00819398020220Lowenstein-Jensen with 5% NaCl, 20x125mm Tube, 10ml Slant. Hardy Diagnostics Lowenstein-Jensen
00819398020206LJ with Pyruvate, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommend
00819398020183Lowenstein Jensen Medium, 20x125mm Tube, 5ml Deep. Hardy Diagnostics Lowenstein Jensen Deep is
00819398020169LJ, Selective, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended
00819398020145LJ, Gruft Modification, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are rec
00819398020121Lowenstein Jensen, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommen

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