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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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N/A - 00816576024933

Bile Esculin Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Bile Esculin Agar (BEA) is recommended for use as a differential medium in the isolation and presumptive identification of enterococci/group D streptococci.
HARDY DIAGNOSTICS
G12
In Commercial Distribution

  • 00816576024926 ()
  • 00816576024933 ()
G12

  • Differential/selective agar culture medium IVD

N/A - 00816576024919

CGB Agar, 15x100mm Plate, 20ml. Hardy Diagnostics CGB Agar is recommended for the differentiation of Cryptococcus neoformans var. neoformans and Cryptococcus gattii (formerly C. neoformans var. gattii).
HARDY DIAGNOSTICS
G113
In Commercial Distribution

  • 00816576024902 ()
  • 00816576024919 ()
G113

  • Differential/selective agar culture medium IVD

N/A - 00816576024896

Bile Esculin Agar (BEA) with Azide, 15x100mm Plate, 18ml. Hardy Diagnostics Bile Esculin with Azide Media are recommended for the isolation and differentiation of group D streptococci from non-group D streptococci.
HARDY DIAGNOSTICS
G11
In Commercial Distribution

  • 00816576024889 ()
  • 00816576024896 ()
G11

  • Differential/selective agar culture medium IVD

N/A - 00816576024858

PPLO Selective Agar, 15x100mm Plate, 18ml. Hardy Diagnostics PPLO Media are recommended for the cultivation and maintenance of Mycoplasma spp. and Ureaplasma spp.
HARDY DIAGNOSTICS
G105
In Commercial Distribution

  • 00816576024841 ()
  • 00816576024858 ()
G105

  • Differential/selective agar culture medium IVD

N/A - 00816576024834

Corn Meal with Tween® 80, 15x60mm Plate, 13ml. Hardy Diagnostics Corn Meal Agar with Tween® 80 is recommended for use in the cultivation of fungi and for the inducement of chlamydospore formation by Candida albicans.
HARDY DIAGNOSTICS
G101
Not in Commercial Distribution

  • 00816576024827 ()
  • 00816576024834 ()
G101

  • Differential/selective agar culture medium IVD

N/A - 00816576024810

Burkholderia cepacia Selective Agar (BCSA), USP, 15x100mm Plate, 18ml. Hardy Diagnostics Burkholderia cepacia Selective Agar (BCSA), USP is recommended for the selective isolation and differentiation of Burkholderia cepacia from sputum samples from cystic fibrosis patients and other clinical specimens. In addition, the medium complies with the U.S. Pharmacopoeia <60> for the Microbial Examination of Non-sterile Products–Tests for Burkholderia cepacia complex.
HARDY DIAGNOSTICS
G09
In Commercial Distribution

  • 00816576024803 ()
  • 00816576024810 ()
G09

  • Differential/selective agar culture medium IVD

N/A - 00816576024797

BCYE Selective Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
HARDY DIAGNOSTICS
G08
In Commercial Distribution

  • 00816576024780 ()
  • 00816576024797 ()
G08

  • Differential/selective agar culture medium IVD

N/A - 00816576024759

Campy, Blood-Free Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Campy, Blood-Free Agar is a selective medium recommended for the isolation and cultivation of Campylobacter jejuni , C. coli, and C. laridis from feces.
HARDY DIAGNOSTICS
G06
In Commercial Distribution

  • 00816576024742 ()
  • 00816576024759 ()
G06

  • Differential/selective agar culture medium IVD

N/A - 00816576024735

BBE Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Bacteroides Bile Esculin Agar (BBE) is recommended for use in the rapid isolation and presumptive identification of Bacteroides fragilis group.
HARDY DIAGNOSTICS
G05
In Commercial Distribution

  • 00816576024384 ()
  • 00816576024735 ()
G05

  • Differential/selective agar culture medium IVD

N/A - 00816576024728

PPLO Selective Agar, 15x60mm Plate, 11ml. Hardy Diagnostics PPLO Media are recommended for the cultivation and maintenance of Mycoplasma spp. and Ureaplasma spp.
HARDY DIAGNOSTICS
G04
In Commercial Distribution

  • 00816576024711 ()
  • 00816576024728 ()
G04

  • Differential/selective agar culture medium IVD

N/A - 00816576024704

A8 Agar, 15x60mm Plate, 11ml. Hardy Diagnostics A8 Agar is used for isolation and differentiation of genital mycoplasmas, i.e. Ureaplasma urealyticum and Mycoplasma hominis.
HARDY DIAGNOSTICS
G02
In Commercial Distribution

  • 00816576024698 ()
  • 00816576024704 ()
G02

  • Differential/selective agar culture medium IVD

N/A - 00816576024681

YM-11 Agar, 15x100mm Plate, 18ml. Hardy Diagnostics YM-11 Agar is recommended for the isolation of yeast and molds.
HARDY DIAGNOSTICS
G01
In Commercial Distribution

  • 00816576024674 ()
  • 00816576024681 ()
G01

  • Differential/selective agar culture medium IVD

N/A - 00816576024643

BCYE Agar with GVPC, without Cysteine, 15x100mm plate, order by the package of 10 Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria
HARDY DIAGNOSTICS
W76
In Commercial Distribution

  • 00816576023448 ()
  • 00816576024643 ()
W76

  • Differential/selective agar culture medium IVD

N/A - 00816576024636

Selenite Cystine Broth, 20ml For the selective enrichment of Salmonella spp. Cystine enhances growth of Salmonella spp.
HARDY DIAGNOSTICS
K120
In Commercial Distribution

  • 00816576024582 ()
  • 00816576024636 ()
K120

  • Differential/selective broth culture medium IVD

N/A - 00816576024599

Cetrimide Selective Agar (CET) / MacConkey Agar (MAC) / Vogel and Johnson Agar (VJ), 15x100mm triplate, 7ml/section. Hardy Diagnostics Cetrimide Selective Agar is recommended for the selective isolation and identification of Pseudomonas aeruginosa. Hardy Diagnostics MacConkey Agar is recommended for use as a selective and differential medium for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens), on the basis of lactose fermentation. Hardy Diagnostics Vogel and Johnson Agar is a selective medium used for the detection of coagulase-positive, mannitol-positive Staphylococcus aureus strains in clinical specimens and foods.
HARDY DIAGNOSTICS
J314
In Commercial Distribution

  • 00816576023363 ()
  • 00816576024599 ()
J314

  • Multiple formulation agar culture medium IVD

N/A - 00816576024568

Chocolate with Bacitracin, 15x100mm Plate, 18ml. Hardy Diagnostics Chocolate Agar with Bacitracin is recommended for use in the isolation and cultivation of Haemophilus species from respiratory specimens containing mixed flora.
HARDY DIAGNOSTICS
E11
In Commercial Distribution

  • 00816576024551 ()
  • 00816576024568 ()
E11

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024544

Anaerobic PEA, Monoplate. Hardy Diagnostics AnaeroGRO™ Anaerobic PEA Agar is recommended for use as an enriched and selective medium for the cultivation and selective isolation of gram-positive and negative obligate anaerobic bacteria. It is useful in isolating obligate anaerobes from mixed flora, by inhibiting gram-negative facultative anaerobes and the control of swarming organisms.
HARDY DIAGNOSTICS
AG901
Not in Commercial Distribution

  • 00816576024544 ()
AG901

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024520

LKV Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ LKV (Laked Blood with Kanamycin and Vancomycin) Agar is recommended for use in the selective isolation and partial identification of obligately anaerobic gram-negative bacilli, such as Prevotella spp. and Bacteroides spp.
HARDY DIAGNOSTICS
AG601
Not in Commercial Distribution

  • 00816576024520 ()
AG601

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024513

Cycloserine-Cefoxitin Fructose Agar, 15x100mm Plate, 18ml. Hardy Diagnostics AnaeroGRO™ Cycloserine-Cefoxitin Fructose Agar (CCFA) is an enriched selective and differential medium recommended for the isolation and cultivation of Clostridium difficile from fecal specimens. C. difficile is a recognized cause of intestinal infections and pseudomembranous colitis following antibiotic therapy.
HARDY DIAGNOSTICS
AG501
Not in Commercial Distribution

  • 00816576024513 ()
AG501

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024506

Egg Yolk Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics AnaeroGRO™ Egg Yolk Agar, Modified is an enriched, non-selective, and differential medium recommended for use in the detection of lecithinase and lipase production and proteolytic activity of certain obligate anaerobes and in the presumptive identification of various Clostridium, Fusobacterium, and Prevotella spp.; it is also used in the Nagler Test for the presumptive identification of Clostridium perfringens.
HARDY DIAGNOSTICS
AG401
In Commercial Distribution

  • 00816576024506 ()
AG401

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024391

Bacteroides Bile Esculin Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selective, and differential medium recommended for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila spp.
HARDY DIAGNOSTICS
AG051
Not in Commercial Distribution

  • 00816576024391 ()
AG051

  • Differential/selective agar culture medium IVD

N/A - 00816576024353

PEA with 5% Sheep Blood, 15x100mm Plate, 18ml. Hardy Diagnostics PEA with 5% Sheep Blood is a selective medium recommended for the isolation of gram-positive microorganisms, particularly gram-positive cocci, from mixed specimens.
HARDY DIAGNOSTICS
A93
In Commercial Distribution

  • 00816576024346 ()
  • 00816576024353 ()
A93

  • Differential/selective agar culture medium IVD

N/A - 00816576024339

Anaerobic PEA, 15x100mm Plate, 18ml. Hardy Diagnostics Anaerobic PEA Agar is recommended for use as an enriched medium for the cultivation and selective isolation of gram-positive and negative obligate anaerobic bacteria.
HARDY DIAGNOSTICS
A90
In Commercial Distribution

  • 00816576024322 ()
  • 00816576024339 ()
A90

  • Differential/selective agar culture medium IVD

N/A - 00816576024278

Group A Beta Strep Agar, 15x100mm Plate, 17ml Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
A72
In Commercial Distribution

  • 00816576024261 ()
  • 00816576024278 ()
A72

  • Differential/selective agar culture medium IVD

N/A - 00816576024230

Selective Strep Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Selective Strep Agar is a selective medium recommended for use in the primary isolation of all Streptococcus species, including streptococcal groups A (S. pyogenes), B (S. agalactiae), C, D, F, G, and S. pneumoniae, especially from repiratory specimens.
HARDY DIAGNOSTICS
A70
In Commercial Distribution

  • 00816576024223 ()
  • 00816576024230 ()
A70

  • Differential/selective agar culture medium IVD

N/A - 00816576024193

Rose Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Rose Agar is recommended for use as a selective growth medium for the cultivation and isolation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora.
HARDY DIAGNOSTICS
A66
In Commercial Distribution

  • 00816576024186 ()
  • 00816576024193 ()
A66

  • Differential/selective agar culture medium IVD

N/A - 00816576024179

Regan-Lowe Agar, 15x100mm Plate, 22ml. Hardy Diagnostics Regan-Lowe Agar is a selective medium recommended for the isolation and cultivation of Bordetella spp. Regan-Lowe Agar without Cephalexin does not contain selective agents and is recommended for the cultivation of Bordetella.
HARDY DIAGNOSTICS
A65
In Commercial Distribution

  • 00816576024162 ()
  • 00816576024179 ()
A65

  • Differential/selective agar culture medium IVD

N/A - 00816576024155

Regan-Lowe Agar without Cephalexin, 15x100mm Plate, 24ml. Hardy Diagnostics Regan-Lowe Agar is a selective medium recommended for the isolation and cultivation of Bordetella spp. Regan-Lowe Agar without Cephalexin does not contain selective agents and is recommended for the cultivation of Bordetella.
HARDY DIAGNOSTICS
A63
In Commercial Distribution

  • 00816576024148 ()
  • 00816576024155 ()
A63

  • Differential/selective agar culture medium IVD

N/A - 00816576024131

Neomycin Anaerobic Blood Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Neomycin Anaerobic Agar is recommended for use in the primary isolation of fastidious anaerobic microorganisms.
HARDY DIAGNOSTICS
A62
In Commercial Distribution

  • 00816576024124 ()
  • 00816576024131 ()
A62

  • Differential/selective agar culture medium IVD

N/A - 00816576024117

LKV Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Laked Blood with Kanamycin and Vancomycin Agar is recommended for use in the isolation and partial identification of anaerobic microorganisms.
HARDY DIAGNOSTICS
A60
In Commercial Distribution

  • 00816576024100 ()
  • 00816576024117 ()
A60

  • Differential/selective agar culture medium IVD

N/A - 00816576024094

Columbia CNA, 15x100 monoplate, 10/pks of 10 (Columbia Agar with 5% Sheep Blood, Colistin, and Nalidixic Acid) For the selective isolation of gram positive bacteria.
HARDY DIAGNOSTICS
A50BX
In Commercial Distribution

  • 00816576024070 ()
  • 00816576024094 ()
A50BX

  • Differential/selective agar culture medium IVD

N/A - 00816576024087

Columbia CNA, 15x100 monoplate, 10/pk (Columbia Agar with 5% Sheep Blood, Colistin, and Nalidixic Acid) For the selective isolation of gram positive bacteria.
HARDY DIAGNOSTICS
A50
In Commercial Distribution

  • 00816576024070 ()
  • 00816576024087 ()
A50

  • Differential/selective agar culture medium IVD

N/A - 00816576024063

Campy CVA Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Campy CVA Agar Plates are recommended for the selective isolation of Campylobacter species from fecal specimens.
HARDY DIAGNOSTICS
A40
In Commercial Distribution

  • 00816576024056 ()
  • 00816576024063 ()
A40

  • Differential/selective agar culture medium IVD

N/A - 00816576024049

GBS Detect, 15x100 monoplate, 10pks of 10 For the isolation and differentiation by enhanced hemolysis of gamma hemolytic Group B Streptococcus
HARDY DIAGNOSTICS
A300BX
In Commercial Distribution

  • 00816576024025 ()
  • 00816576024049 ()
A300BX

  • Differential/selective agar culture medium IVD

N/A - 00816576024032

GBS Detect, 15x100 monoplate, 10/pk For the isolation and differentiation by enhanced hemolysis of gamma hemolytic group B Streptococcus.
HARDY DIAGNOSTICS
A300
In Commercial Distribution

  • 00816576024025 ()
  • 00816576024032 ()
A300

  • Differential/selective broth culture medium IVD

N/A - 00816576023899

StrePlate™, 15x100mm Monoplate, 22ml. Hardy Diagnostics' Bacti-Lab StrePlate™ is on enriched media for the selective isolation of all Streptococcus spp., including beta-hemolytic group A (Streptococcus pyogenes), group B (Streptococcus agalactiae), groups C, D, F and G; and Streptococcus pneumoniae.
HARDY DIAGNOSTICS
A150
In Commercial Distribution

  • 00816576023882 ()
  • 00816576023899 ()
A150

  • Differential/selective agar culture medium IVD

N/A - 00816576023851

Campy FDA Agar, 15x100, 10/pk (Campylobacter FDA Agar with amphotericin, novobiocin, polymyxin, trimethoprim, and vancomycin). For the isolation and cultivation of Campylobacter spp.
HARDY DIAGNOSTICS
A139
In Commercial Distribution

  • 00816576023844 ()
  • 00816576023851 ()
A139

  • Differential/selective agar culture medium IVD

N/A - 00816576023837

Campylobacter Blood Agar, 15x100mm plate, 18ml. Hardy Diagnostics Campylobacter Blood Agar is recommended for the primary isolation and cultivation of Campylobacter jejuni from human fecal specimens.
HARDY DIAGNOSTICS
A137
In Commercial Distribution

  • 00816576023820 ()
  • 00816576023837 ()
A137

  • Differential/selective agar culture medium IVD

N/A - 00816576023813

Arcanobacterium Selective Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Arcanobacterium Selective Agar is recommended for use as a selective medium for the isolation of Arcanobacterium haemolyticum, especially from respiratory specimens.
HARDY DIAGNOSTICS
A134
Not in Commercial Distribution

  • 00816576023806 ()
  • 00816576023813 ()
A134

  • Differential/selective agar culture medium IVD

N/A - 00816576023790

Campy Cefex Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics Campy Cefex Agar, Modified plates are recommended for the selective isolation of cephalothin-resistant Campylobacter species such as C. jejuni , C. coli , and C. lari from human, animal, or food samples.
HARDY DIAGNOSTICS
A122
In Commercial Distribution

  • 00816576023783 ()
  • 00816576023790 ()
A122

  • Differential/selective agar culture medium IVD

N/A - 00816576023776

Blood Agar with Ampicillin, 15x100mm Plate, 17ml. Hardy Diagnostics Blood Agar with Ampicillin is recommended for the cultivation and selective isolation of Aeromonas spp.
HARDY DIAGNOSTICS
A12
In Commercial Distribution

  • 00816576023769 ()
  • 00816576023776 ()
A12

  • Differential/selective agar culture medium IVD

N/A - 00816576023547

Potato Dextrose Agar, 15x100, 10/pk For the cultivation of yeasts and molds.
HARDY DIAGNOSTICS
1052
Not in Commercial Distribution

  • 00816576023530 ()
  • 00816576023547 ()
1052

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576023523

DTM Agar (Dermatophyte Test Medium) A selective and differential medium for the detection and presumptive identification of dermatophytes from clinical and veterinary specimens
HARDY DIAGNOSTICS
1020
Not in Commercial Distribution

  • 00816576023516 ()
  • 00816576023523 ()
1020

  • Differential/selective agar culture medium IVD

HardyCHROM - 00816576023370

HardyCHROM Candida + auris Recommended for the selective isolation and differential identification of yeast. The medium allows for the differentiation of C. albicans , C. tropicalis, C. krusei, and C. auris based on colony morphology, color, and positive UV fluorescence. This medium facilitates the detection of mixed yeast cultures.
HARDY DIAGNOSTICS
G343
In Commercial Distribution

  • 00816576023103 ()
  • 00816576023370 ()
G343

  • Differential/selective agar culture medium IVD

N/A - 00816576023233

SabDex, USP, 26ml, red mono, no ink jet. (Sabourad Dextrose Agar, Red Tint Plate) For the cultivation of fungi.
HARDY DIAGNOSTICS
W70R
Not in Commercial Distribution

  • 00816576023240 ()
  • 00816576023233 ()
W70R

  • Basic/simple nutrient agar culture medium IVD

Remel - 00842558108605

SPECTRA Strep A Agar 10/PK
REMEL, INC.
R01812
In Commercial Distribution

  • 30842558108606 ()
  • 00842558108605 ()


  • Differential/selective agar culture medium IVD

BD BBL™ Trypticase™ Soy Broth - 00382902973805

BD BBL™ Trypticase™ Soy Broth
BECTON, DICKINSON AND COMPANY
297380
In Commercial Distribution

  • 00382902973805 ()
297380

  • Enriched broth culture medium IVD

HardyCHROM - 10819398028421

HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromogenic medium recommended for the selective isolation and differentiation of Cronobacter (Enterobacter) sakazakii from other members of the family Enterobacteriaceae based on colony color.
HARDY DIAGNOSTICS
G315
Not in Commercial Distribution

  • 00819398028424 ()
  • 10819398028421 ()
G315

  • Differential/selective agar culture medium IVD

ACU-NICKERSON - 10814105021238

ACU-NICKERSON, 24/Bx
ACUDERM, INC.
M104
In Commercial Distribution

  • 00814105021231 ()
  • 10814105021238 ()


  • Candida albicans microbial identification reagent IVD

ACU-DTM - 10814105021214

ACU-DTM, Dermatophyte Test Medium, 24/bX
ACUDERM, INC.
M101
In Commercial Distribution

  • 00814105021217 ()
  • 10814105021214 ()


  • Multiple dermatophyte species culture isolate identification IVD, kit
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