N/A J139

GUDID 00816576026586

Hektoen Enteric (HE) Agar / SS Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective and differential medium used for the isolation and differentiation of gram-negative enteric pathogens. Hardy Diagnostics SS Agar is recommended for use as a selective and differential medium for the isolation of Salmonella and some Shigella species from clinical and non-clinical specimens.

HARDY DIAGNOSTICS

Multiple formulation agar culture medium IVD
Primary Device ID00816576026586
NIH Device Record Key2bd4dd5a-aa1a-4cf7-8997-9e6aeea78f5a
Commercial Distribution Discontinuation2024-04-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameN/A
Version Model NumberJ139
Catalog NumberJ139
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
Device Count10
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
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
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
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
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
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
GS100816576026586 [Unit of Use]
GS100816576026593 [Primary]

FDA Product Code

JSICulture Media, Selective And Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-04-05
Device Publish Date2020-05-20

On-Brand Devices [N/A]

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00819398026482Strep B Carrot Broth™ One-Step, 13x100mm Tube, 4ml Strep B Carrot Broth™ One-Step is a selec
00816576023882StrePlate™, 15x100mm Monoplate, 22ml. Hardy Diagnostics' Bacti-Lab StrePlate™ is on enriche
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
00816576023806Arcanobacterium Selective Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Arcanobacterium Selecti
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
00816576023714Blood Agar EH, 5%, 15x100mm Plate, 17ml Hardy Diagnostics Blood Agar Enhanced Hemolysis (EH) is
00819398023917LJ with Iron, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended f
00819398020381Trichophyton Agar #3, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers
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
00816576025428CLED Agar, 15x100mm Plate, 18ml. Hardy Diagnostics CLED Agar is recommended for the isolation,
00816576025381Pseudomonas Isolation Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Pseudomonas Isolation Agar
00816576025367Egg Yolk Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics Egg Yolk Agar, Modified is rec
00816576025343Caffeic Acid Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Caffeic Acid Agar Slant is recommend
00816576025329SP4 Agar with Glucose, 15x60mm Plate, 11ml. Hardy Diagnostics SP4 Media are recommended for the
00816576025305BCYE Agar with DGVP, 15x100mm Plate, 18ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (B
00816576025268Pseudomonas Agar P, 15x100mm Plate, 18ml. Pseudomonas Agar P, also known as Tech Agar, is recom
00816576025244CIN Agar, 15x100mm Plate, 18ml. Hardy Diagnostics CIN Agar is recommended for use in the select
00816576025220Pseudomonas Agar F, 15x100mm Plate, 18ml. Hardy Diagnostics Pseudomonas Agar F is used for the
00816576025206Vogel and Johnson Agar, 15x100mm Plate, 19ml. Hardy Diagnostics Vogel and Johnson Agar is a sel
00816576025183Cetrimide Selective Agar, USP, 15x100mm Plate, 26ml. Hardy Diagnostics Cetrimide Selective Agar
00816576025169BCYE Agar with CCVC, 15x100mm plate, 24ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (B
00816576025145BiGGY Agar, 15x100mm Plate, 18ml. Hardy Diagnsotics BiGGY Agar (Bismuth Sulfite Glucose Glycine
00816576025107PLET Agar, 15x100mm Plate, 20ml. Hardy Diagnostics PLET Agar (Polymyxin-Lysozyme-EDTA-Thallous
00816576025060Pseudomonas Isolation Agar, 15x60mm Plate, 11ml. Hardy Diagnostics Pseudomonas Isolation Agar i
00816576025046PDA with Fildes and Nafcillin, 15x100mm Plate, 19ml. Hardy Diagnostics Peptic Digest Agar (PDA)
00816576025008MacConkey Agar with Sorbitol, Cefixime, and Tellurite, 15x100mm Plate, 18ml. Hardy Diagnostics
00816576024988Granada Medium, 15x100mm Plate, 19ml. Granada Medium is a selective and differential agar which
00816576024964Casein Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Casein Agar is recommended for use as a me
00816576024926Bile Esculin Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Bile Esculin Agar (BEA) is recommend
00816576024902CGB Agar, 15x100mm Plate, 20ml. Hardy Diagnostics CGB Agar is recommended for the differentiati
00816576024889Bile Esculin Agar (BEA) with Azide, 15x100mm Plate, 18ml. Hardy Diagnostics Bile Esculin with A
00816576024865BCYE Agar without Cysteine, 15x100mm Plate, 18ml. Hardy Diagnostics Buffered Charcoal Yeast Ext
00816576024841PPLO Selective Agar, 15x100mm Plate, 18ml. Hardy Diagnostics PPLO Media are recommended for the
00816576024827Corn Meal with Tween® 80, 15x60mm Plate, 13ml. Hardy Diagnostics Corn Meal Agar with Tween® 8
00816576024803Burkholderia cepacia Selective Agar (BCSA), USP, 15x100mm Plate, 18ml. Hardy Diagnostics Burkho
00816576024780BCYE Selective Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (B
00816576024766BCYE Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar
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