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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 - 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

N/A - 00816576027590

Nutrient Agar Plate, 15x100mm plate (without plate label), order by the package of 10 For the cultivation of non-fastidious microorganisms.
HARDY DIAGNOSTICS
W31
Not in Commercial Distribution

  • 00816576027583 ()
  • 00816576027590 ()
W31

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027552

Malt Extract Agar, deep fill, 15x100mm plate, order by the package of 10 For the cultivation and enumeration of yeasts and molds.
HARDY DIAGNOSTICS
W28
In Commercial Distribution

  • 00816576027545 ()
  • 00816576027552 ()
W28

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027538

Inhibitory Mold Agar with Gentamicin, deep fill, 15x100mm plate, order by the package of 10 For the selective isolation of pathogenic fungi. Contains chloramphenicol and gentamicin for inhibition of bacteria.
HARDY DIAGNOSTICS
W27
In Commercial Distribution

  • 00816576027521 ()
  • 00816576027538 ()
W27

  • Differential/selective agar culture medium IVD

N/A - 00816576027514

SabDex Agar, 25x100mm Plate, 60ml deep fill, order by the package of 5 For the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts.
HARDY DIAGNOSTICS
W250
In Commercial Distribution

  • 00816576027507 ()
  • 00816576027514 ()
W250

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027491

Inhibitory Mold Agar (with chloramphenicol), deep fill, 15x100mm plate, order by the package of 10 For the selective isolation of pathogenic fungi. Contains chloramphenicol for inhibition of bacteria.
HARDY DIAGNOSTICS
W25
In Commercial Distribution

  • 00816576027484 ()
  • 00816576027491 ()
W25

  • Differential/selective agar culture medium IVD

N/A - 00816576027453

Emmon's Sabdex (Sabouraud Dextrose) Agar, deep fill, 15x100mm plate, order by the package of 10 Emmons Sabdex agar is recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts.
HARDY DIAGNOSTICS
W20
In Commercial Distribution

  • 00816576027446 ()
  • 00816576027453 ()
W20

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027422

BHI (Brain Heart Infusion) Agar with 5% Sheep Blood, 37ml fill, 25x100mm plate, order by the package of 50 (Brain Heart Infusion Agar with 5% Sheep Blood) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
W185BX
In Commercial Distribution

  • 00816576027415 ()
  • 00816576027422 ()
W185BX

  • Differential/selective agar culture medium IVD

N/A - 00816576027408

BCYE (Buffered Charcoal Yeast Extract) Selective Agar with GPCV antibiotics, for Legionella, 26ml fill, 15x100mm plate, order by the package of 10 (Buffered Charcoal Yeast Extract Agar with Glycine, Vancomycin, Polymyxin, and Cycloheximide) For the selective isolation of Legionella spp.
HARDY DIAGNOSTICS
W169
In Commercial Distribution

  • 00816576027392 ()
  • 00816576027408 ()
W169

  • Differential/selective agar culture medium IVD

N/A - 00816576027385

BHI Agar, 25x100mm Plate, 60ml, order by the package of 5 Hardy Diagnostics Brain Heart Infusion (BHI) Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds.
HARDY DIAGNOSTICS
W163
In Commercial Distribution

  • 00816576027378 ()
  • 00816576027385 ()
W163

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027361

Potato Flake Selective Agar (with Ciprofloxacin and Vancomycin) deep fill, 15x100mm plate, order by the package of 10 For the selective isolation of pathogenic fungi
HARDY DIAGNOSTICS
W159
In Commercial Distribution

  • 00816576027354 ()
  • 00816576027361 ()
W159

  • Differential/selective agar culture medium IVD

N/A - 00816576027125

Haemophilus ID Quadplate, for Haemophilus ID Quadplate consists of four separate formulations, which supply the requirements as follows: RTF Casman Medium, Modified (X- and V-factors) Tryptic Soy Agar (TSA) with Hemin (X-factor) Tryptic Soy Agar (TSA), modified with NAD (V-factor) Chocolate Agar (X- and V-factors) For the differentiation of Haemophilus spp.X and V Factors, 15x100mm quadplate, order by the package of 10
HARDY DIAGNOSTICS
J82
In Commercial Distribution

  • 00816576027118 ()
  • 00816576027125 ()
J82

  • Differential/selective agar culture medium IVD

N/A - 00816576027101

Middlebrook 7H11 / 7H11 Selective Agar, 15x100mm Biplate, 16ml/16ml. Hardy Diagnostics Middlebrook 7H11 Agar is recommended for use in the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
J75
In Commercial Distribution

  • 00816576027095 ()
  • 00816576027101 ()
J75

  • Multiple formulation agar culture medium IVD

N/A - 00816576026999

MacConkey Agar / EMB Agar, Levine, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. 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
J58
In Commercial Distribution

  • 00816576026982 ()
  • 00816576026999 ()
J58

  • Differential/selective agar culture medium IVD

N/A - 00816576026906

Corn Meal with Tween® 80, 15x100mm Biplate, 13ml/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
J48
Not in Commercial Distribution

  • 00816576026890 ()
  • 00816576026906 ()
J48

  • Differential/selective agar culture medium IVD

N/A - 00816576026821

Derm-Duet™, RSM™/DTM, 15x100mm Biplate, 15ml/15ml. Hardy Diagnostics’ Bacti-Lab Skin Culture Systems™ are diagnostic culture test kits for the detection of dermatophytic fungi. The culture media is ready-for-use and provides simplified culture procedures for the isolation, detection and speciation of dermatophytes (Microsporum, Epidermophyton, Trichophyton) commonly seen from hair, skin, and nail specimens in a human or veterinary clinical setting.
HARDY DIAGNOSTICS
J350
In Commercial Distribution

  • 00816576026814 ()
  • 00816576026821 ()
J350

  • Multiple formulation agar culture medium IVD

N/A - 00816576026685

Tryptic Soy Broth (TSB), 10ml, 16x125mm tube, optically clear, order by the package of 10 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth, USP.
HARDY DIAGNOSTICS
6036
Not in Commercial Distribution

  • 00816576026678 ()
  • 00816576026685 ()
6036

  • Basic/simple nutrient broth culture medium IVD

N/A - 00816576026661

Tryptic Soy Broth (TSB), 2ml, 16x100mm tube, order by the package of 10 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also Known as Soybean-Casein Digest Broth, USP.
HARDY DIAGNOSTICS
6034
Not in Commercial Distribution

  • 00816576026616 ()
  • 00816576026661 ()
6034

  • Basic/simple nutrient broth culture medium IVD

N/A - 00816576026609

Thioglycollate w/o Indicator, 10mL,16x125mm tube,10 tubes/box. For the cultivation of microorganisms. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
6020
Not in Commercial Distribution

  • 00816576026463 ()
  • 00816576026609 ()
6020

  • Basic/simple nutrient broth culture medium IVD

N/A - 00816576026593

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
J139
Not in Commercial Distribution

  • 00816576026586 ()
  • 00816576026593 ()
J139

  • Multiple formulation agar culture medium IVD

N/A - 00816576026579

Arcano Select / Group A Beta Strep Biplate, 15x100mm Plate, 10ml/10ml. 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 Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
J134
Not in Commercial Distribution

  • 00816576026562 ()
  • 00816576026579 ()
J134

  • Multiple formulation agar culture medium IVD

N/A - 00816576026500

MacConkey/MacConkey Biplate 15x100 biplate, 10/pk (MacConkey Agar) For the isolation and differentiation of gram-negative bacteria. Some ingredients are very light sensitive. Store and incubate media in the dark
HARDY DIAGNOSTICS
J118
In Commercial Distribution

  • 00816576026494 ()
  • 00816576026500 ()
J118

  • Differential/selective agar culture medium IVD

N/A - 00816576026456

BHI (Brain Heart Infusion) Agar Slant, 16x125mm tube, order by the package of 10 (Brain Heart Infusion Agar) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
6007
Not in Commercial Distribution

  • 00816576026449 ()
  • 00816576026456 ()
6007

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576026432

Bile Esculin Agar Slant, BEA, 16x125mm tube, 10 tubes/pack (Bile Esculin Agar) For the identification of group D streptococci including enterococci.
HARDY DIAGNOSTICS
6001
Not in Commercial Distribution

  • 00816576026371 ()
  • 00816576026432 ()
6001

  • Differential/selective agar culture medium IVD

N/A - 00816576026425

TSA / TSA, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Tryptic Soy Agar is recommended for use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance and transportation of pure cultures of microorganisms.
HARDY DIAGNOSTICS
J108
Not in Commercial Distribution

  • 00816576026418 ()
  • 00816576026425 ()
J108

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576026364

BiGGY Agar Slant (Nickerson's Agar), 6ml, 16x125mm tube, order by the package of 10 For the selective isolation and identification of Candida spp.
HARDY DIAGNOSTICS
6000
In Commercial Distribution

  • 00816576026333 ()
  • 00816576026364 ()
6000

  • Differential/selective agar culture medium IVD

HardyCHROM - 00816576026357

HUrBi™, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ HUrBi™ Biplate is a selective chromogenic medium recommended for the cultivation, differentiation and enumeration of various gram-negative and gram-positive bacteria, and yeast based on colony color and morphology. Selective agents have been added to the each side of the biplate to select for growth of gram-positive organisms and yeast on one side and to select for growth of gram-negative organisms on the other side of the biplate.
HARDY DIAGNOSTICS
J100
In Commercial Distribution

  • 00816576026340 ()
  • 00816576026357 ()
J100

  • Differential/selective agar culture medium IVD

N/A - 00816576026326

Middlebrook 7H11 Selective Agar, 15x100mm Biplate, 16ml/16ml. Hardy Diagnostics Middlebrook 7H11 Agar is recommended for use in the selective isolation of Mycobacterium species. Some ingredients are very light sensitive. Store and incubate media in the dark.
HARDY DIAGNOSTICS
J31
In Commercial Distribution

  • 00816576026074 ()
  • 00816576026326 ()
J31

  • Differential/selective agar culture medium IVD

N/A - 00816576026173

Mannitol Salt Agar (MSA) with Oxacillin, 15x100mm Plate, 18ml. Hardy Diagnostics Mannitol Salt Agar (MSA) with Oxacillin is used as a primary screening medium for the simultaneous detection and differentiation of methicillin resistant Staphylococcus spp. (MRS). It can be used as a cost effective screening method for MRSA.
HARDY DIAGNOSTICS
G97
In Commercial Distribution

  • 00816576026166 ()
  • 00816576026173 ()
G97

  • Differential/selective agar culture medium IVD

N/A - 00816576026159

Baird-Parker Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Baird-Parker Agar is a selective medium for the detection and enumeration of coagulase-positive staphylococci from food samples.
HARDY DIAGNOSTICS
G96
In Commercial Distribution

  • 00816576026142 ()
  • 00816576026159 ()
G96

  • Differential/selective agar culture medium IVD

N/A - 00816576026135

Potato Dextrose Agar with TA (Tartaric Acid), 15x60mm Plate, 13ml. Hardy Diagnostics Potato Dextrose Agar with TA (Tartaric Acid) is recommended for the microbial examination of food and dairy products.
HARDY DIAGNOSTICS
G94
In Commercial Distribution

  • 00816576026128 ()
  • 00816576026135 ()
G94

  • Differential/selective agar culture medium IVD

N/A - 00816576026050

XLD (Xylose Lysine Deoxycholate) Agar, USP, 15x100 monoplate, 10/pk XLD Agar, USP is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens. The U.S. Pharmacopeia National Formulary (USP) describes the use of XLD Agar for growth promotion and indication of Salmonella in the microbiological examination of nonsterile products.
HARDY DIAGNOSTICS
G65
In Commercial Distribution

  • 00816576026043 ()
  • 00816576026050 ()
G65

  • Differential/selective agar culture medium IVD

N/A - 00816576026036

Hektoen Enteric (HE) Agar, 15x100mm Plate, 18ml. 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
G63
In Commercial Distribution

  • 00816576026029 ()
  • 00816576026036 ()
G63

  • Differential/selective agar culture medium IVD

N/A - 00816576026012

Tryptic Soy Agar (TSA) (without plate label, orientation tabs, and logo), 15x100ml Plate, 23ml. Hardy Diagnostics Tryptic Soy Agar is recommended for use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance and transportation of pure cultures of microorganisms.
HARDY DIAGNOSTICS
G62
Not in Commercial Distribution

  • 00816576026005 ()
  • 00816576026012 ()
G62

  • Differential/selective agar culture medium IVD

N/A - 00816576025992

TSA Plate, USP, 15x100 monoplate, 10 packs/case (Tryptic Soy Agar) For the cultivation of microorganisms
HARDY DIAGNOSTICS
G60BX
In Commercial Distribution

  • 00816576025978 ()
  • 00816576025992 ()
G60BX

  • Basic/simple nutrient agar culture medium IVD
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