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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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Microbank Yellow (80 vials) - 10628429000592

Single vials of Microbank™
PRO-LAB, INCORPORATED
PL.160Y
In Commercial Distribution

  • 10628429000592 ()
PL.160Y

  • Basic/simple nutrient broth culture medium IVD

Microbank Red (80 vials) - 10628429000585

Single vials of Microbank™
PRO-LAB, INCORPORATED
PL.160R
In Commercial Distribution

  • 10628429000585 ()
PL.160R

  • Basic/simple nutrient broth culture medium IVD

Microbank Light Blue (80 vials) - 10628429000578

Single vials of Microbank™
PRO-LAB, INCORPORATED
PL.160LB
In Commercial Distribution

  • 10628429000578 ()
PL.160LB

  • Basic/simple nutrient broth culture medium IVD

Microbank Green (80 vials) - 10628429000561

Single vials of Microbank™
PRO-LAB, INCORPORATED
PL.160G
In Commercial Distribution

  • 10628429000561 ()
PL.160G

  • Basic/simple nutrient broth culture medium IVD

Microbank Blue (80 vials) - 10628429000554

Single vials of Microbank™
PRO-LAB, INCORPORATED
PL.160B
In Commercial Distribution

  • 10628429000554 ()
PL.160B

  • Basic/simple nutrient broth culture medium IVD

Alpha-Tec Systems - 00816085023670

ETM/Clean Vial 25 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023663 ()
  • 00816085023670 ()
0003371

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085023663

ETM/Clean Vial bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023663 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022857

ETM 50 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022857 ()
0003367

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022673

ETM With CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022673 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022284

ETM / Clean Microvials bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022284 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022253

ETM (micro) bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022253 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022185

ETM® / Clean Microvials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022185 ()
0003725

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022123

ETM Microvials 64 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022123 ()
0003701

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022635

ETM bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022635 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022628

ETM® 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022635 ()
  • 00816085022628 ()
0003330

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022567

ETM With CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022673 ()
  • 00816085022567 ()
0003316

  • Faecal specimen collection kit IVD, home-use

HardyCHROM - 00816576029105

HardyCHROM Group A Strep Agar (RSR) A chromogenic medium recommended for the selective cultivation and differential isolation of Group A Streptococcus (S. pyogenes) from specimens based on colony color. Some ingredients are very light sensitive. Store and incubate in the dark.
HARDY DIAGNOSTICS
GA337
Not in Commercial Distribution

  • 00816576029112 ()
  • 00816576029105 ()
GA337

  • Differential/selective agar culture medium IVD

HardyCHROM - 00816576029099

HardyCHROM Group A Strep Agar A chromogenic medium recommended for the selective cultivation and differential isolation of Group A Streptococcus (S. pyogenes) from specimens based on colony color. Some ingredients are very light sensitive. Store and incubate in the dark.
HARDY DIAGNOSTICS
G337
In Commercial Distribution

  • 00816576029082 ()
  • 00816576029099 ()
G337

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576029013

AnaeroGRO™ Campylobacter Selective Agar, 15x100mm plate, 1 Pre-reduced plate per mylar pouch AnaeroGRO™ Campylobacter Selective Agar is recommended for the selective isolation of Campylobacter jejuni subsp. jejuni from stool specimens. Growth of normal fecal flora is inhibited on this medium.
HARDY DIAGNOSTICS
AG701
Not in Commercial Distribution

  • 00816576029013 ()
AG701

  • Differential/selective agar culture medium IVD

N/A - 00816576028542

Malt Extract Agar, 15x150mm Plate, 68ml. Hardy Diagnostics Malt Extract Agar is recommended for the cultivation, isolation, and maintenance of yeasts and molds.
HARDY DIAGNOSTICS
H57
Not in Commercial Distribution

  • 00816576028535 ()
  • 00816576028542 ()
H57

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576028511

Modified Oxford Medium, 15x100 monoplate, 10/pk (Oxford Listeria Agar) For the selective isolation and differentiation of Listeria monocytogenes
HARDY DIAGNOSTICS
GA46
Not in Commercial Distribution

  • 00816576027064 ()
  • 00816576028511 ()
GA46

  • Differential/selective agar culture medium IVD

N/A - 00816576028184

MEA with Chloramphenicol ,15x100 monoplate 10/pk For the isolation, cultivation, and enumeration of yeast and mold.
HARDY DIAGNOSTICS
W92
In Commercial Distribution

  • 00816576028177 ()
  • 00816576028184 ()
W92

  • Differential/selective agar culture medium IVD

HardyCHROM - 00816576028146

HardyCHROM™ Salmonella / XLT-4 Agar, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ Salmonella is a chromogenic medium recommended for the selective isolation and differentiation of Salmonella spp. from other members of the family Enterobacteriaceae based on colony color. Hardy Diagnostics XLT-4 Agar is a highly selective plating medium for the detection and isolation of non-typhi Salmonella species.
HARDY DIAGNOSTICS
J37
In Commercial Distribution

  • 00816576028139 ()
  • 00816576028146 ()
J37

  • Multiple formulation agar culture medium IVD

N/A - 00816576028023

GBS Detect™, 15x100mm Plate, 17ml (reduced stacking ring). Hardy Diagnostics GBS Detect™ is recommended for the isolation and differentiation by enhanced hemolysis of detection of gamma-hemolytic (non-hemolytic) Group B Streptococcus from GBS enrichment broth procedures.
HARDY DIAGNOSTICS
GA300
In Commercial Distribution

  • 00816576028016 ()
  • 00816576028023 ()
GA300

  • Differential/selective agar culture medium IVD

N/A - 00816576028009

Burkholderia cepacia Selective Agar (BCSA), USP, 15x100mm Plate, 18ml (reduced staking ring). 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
GA09
In Commercial Distribution

  • 00816576027996 ()
  • 00816576028009 ()
GA09

  • Differential/selective agar culture medium IVD

N/A - 00816576027965

Liver Infusion Agar Selective, 15x100mm plate, order by the package of 10 (Liver Infusion Selective Agar with Polymyxin B, Nalidixic acid and Vancomycin) For the selective isolation of fungi.
HARDY DIAGNOSTICS
W95
In Commercial Distribution

  • 00816576027958 ()
  • 00816576027965 ()
W95

  • Differential/selective agar culture medium IVD

N/A - 00816576027934

Potato Dextrose Agar with Chloramphenicol, 15x100mm plate, 28ml fill, order by the package of 100 Recommended for the selective cultivation of fungi from mixed samples.
HARDY DIAGNOSTICS
W94BX
In Commercial Distribution

  • 00816576027927 ()
  • 00816576027934 ()
W94BX

  • Differential/selective agar culture medium IVD

N/A - 00816576027897

Malt Extract Agar with 0.01% Chloramphenicol, deep fill, 15x100mm plate, order by the package of 10 For the selective isolation of fungi.
HARDY DIAGNOSTICS
W80
In Commercial Distribution

  • 00816576027880 ()
  • 00816576027897 ()
W80

  • Differential/selective agar culture medium IVD

N/A - 00816576027873

SabHI Agar, (Sabdex and Brain Heart Infusion) deep fill, 15x100mm plate, order by the package of 10 For the cultivation of fungi. A combination of Sabouraud Dextrose and Brain Heart Infusion Agar.
HARDY DIAGNOSTICS
W75
In Commercial Distribution

  • 00816576027866 ()
  • 00816576027873 ()
W75

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027859

Sabdex (Sabouraud Dextrose) Agar with Chloramphenicol and Tetracycline, deep fill, 15x100mm plate, order by the package of 10 (Sabouraud Dextrose Agar with Chloramphenicol and Tetracycline) For the selective isolation of fungi.
HARDY DIAGNOSTICS
W74
In Commercial Distribution

  • 00816576027842 ()
  • 00816576027859 ()
W74

  • Differential/selective agar culture medium IVD

N/A - 00816576027835

Sabdex (Sabouraud Dextrose) with Chloramphenicol and Gentamicin, deep fill, 15x100mm plate, order by the package of 10 For the selective isolation of fungi.
HARDY DIAGNOSTICS
W73
In Commercial Distribution

  • 00816576027828 ()
  • 00816576027835 ()
W73

  • Differential/selective agar culture medium IVD

N/A - 00816576027811

Sabdex (Sabouraud Dextrose) Agar with Chloramphenicol, deep fill, 15x100mm plate, order by the package of 10 (Sabourauds Dextrose Agar with Chloramphenicol) For the selective isolation of fungi and yeasts from clinical and nonclinical specimens.
HARDY DIAGNOSTICS
W72
In Commercial Distribution

  • 00816576027804 ()
  • 00816576027811 ()
W72

  • Differential/selective agar culture medium IVD

N/A - 00816576027798

SabDex (Sabouraud Dextrose) Agar, USP, for cultivation of yeast and fungi, 15x100mm plate, order by the package of 10 Sabouraud Dextrose Agar is recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts, and meet the harmonized USP/EP/JP standards for the microbial examination of non sterile products.
HARDY DIAGNOSTICS
W70
In Commercial Distribution

  • 00816576027781 ()
  • 00816576027798 ()
W70

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027774

Nutrient Agar 1.5%, 15x100mm plate, order by the package of 10 A general purpose growth medium recommended for use in the isolation and cultivation of non-fastidious microorganisms.
HARDY DIAGNOSTICS
W68
In Commercial Distribution

  • 00816576027767 ()
  • 00816576027774 ()
W68

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027750

BHI (Brain Heart Infusion) Agar with Blood, Chloramphenicol and Gentamicin, deep fill, 15x100mm plate, order by the package of 10 (Brain Heart Infusion Agar with 5% Sheep Blood, Chloramphenicol and Gentamicin.)
HARDY DIAGNOSTICS
W65
In Commercial Distribution

  • 00816576027743 ()
  • 00816576027750 ()
W65

  • Differential/selective agar culture medium IVD

N/A - 00816576027736

Potato Dextrose Agar, USP, deep fill, 15x100mm plate, order by the package of 10 Potato Dextrose Agar (PDA), USP is recommended for the cultivation of yeast and mold, and for the inducement of sporulation in non-clinical samples. Potato Dextrose Agar (PDA), USP is formulated as outlined by the U.S. Pharmacopoeia for the preparation of test strains used in microbial enumeration tests.
HARDY DIAGNOSTICS
W60
In Commercial Distribution

  • 00816576027729 ()
  • 00816576027736 ()
W60

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027712

Potato Flake Agar, deep fill, 15x100mm plate, order by the package of 10 For the cultivation of fungi. Induces conidia and spore formation.
HARDY DIAGNOSTICS
W59
In Commercial Distribution

  • 00816576027705 ()
  • 00816576027712 ()
W59

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027699

Inhibitory Mold Agar, 60ml, 25x100mm plate, order by the package of 5 Recommended for the selective isolation of fungi.
HARDY DIAGNOSTICS
W58
In Commercial Distribution

  • 00816576027682 ()
  • 00816576027699 ()
W58

  • Differential/selective agar culture medium IVD

N/A - 00816576027675

Nutrient Agar Plate, deep fill, 15x100mm plate, order by the package of 10 For the cultivation of non-fastidious microorganisms.
HARDY DIAGNOSTICS
W51
In Commercial Distribution

  • 00816576027668 ()
  • 00816576027675 ()
W51

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027651

Mycobiotic Agar, deep fill, 15x100mm plate, order by the package of 10 For the selective isolation of pathogenic fungi especially from hair, skin, and nail specimens. Contains chloramphenicol and cyclohexamide.
HARDY DIAGNOSTICS
W50
In Commercial Distribution

  • 00816576027644 ()
  • 00816576027651 ()
W50

  • Differential/selective agar culture medium IVD

N/A - 00816576027347

BHI (Brain Heart Infusion) Agar, deep fill, 15x100mm plate, order by the package of 10 (Brain Heart Infusion Agar) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
W15
In Commercial Distribution

  • 00816576027330 ()
  • 00816576027347 ()
W15

  • Basic/simple nutrient agar culture medium IVD

N/A - 00816576027323

BCYE Agar with VPC, 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
W79
In Commercial Distribution

  • 00816576027316 ()
  • 00816576027323 ()
W79

  • Differential/selective agar culture medium IVD

N/A - 00816576027309

Czapek Yeast Agar, deep fill, 15x100mm, order by the package of 10 For the isolation and cultivation of yeasts.
HARDY DIAGNOSTICS
W117
Not in Commercial Distribution

  • 00816576027293 ()
  • 00816576027309 ()
W117

  • Differential/selective agar culture medium IVD

N/A - 00816576027286

Corn Meal Agar with Tween® 80, for chlamydospores, deep fill, 15x100mm plate, order by the package of 10 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
W10
In Commercial Distribution

  • 00816576027279 ()
  • 00816576027286 ()
W10

  • Differential/selective agar culture medium IVD

N/A - 00816576026968

G Vag Starch Agar, 15x100mm Monoplate. For the selective isolation and differentiation of Gardnerella vaginalis from other microorganisms found in the female genitourinary tract.
HARDY DIAGNOSTICS
G367
In Commercial Distribution

  • 00816576026951 ()
  • 00816576026968 ()
G367

  • Differential/selective agar culture medium IVD

N/A - 00816576026920

CIN Agar / MacConkey Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics CIN Agar is recommended for use in the selective and differential isolation of Yersinia and Aeromonas species from clinical specimens, environmental samples, and food sources. Hardy Diagnostics MacConkey Agar with Sorbitol is to be used as a selective and differential medium for the detection of enterohemorrhagic Escherichia coli O157:H7.
HARDY DIAGNOSTICS
J49
In Commercial Distribution

  • 00816576026913 ()
  • 00816576026920 ()
J49

  • Multiple formulation agar culture medium IVD

N/A - 00816576026630

Bile Esculin Agar / Sodium Chloride (NaCl) 6.5% without Indicator, 15x100mm Biplate, 10ml/10ml. 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 NaCl 6.5% Media are recommended for use in salt tolerance testing to differentiate Enterococcus from non-enterococcal group D streptococci.
HARDY DIAGNOSTICS
J165
Not in Commercial Distribution

  • 00816576026623 ()
  • 00816576026630 ()
J165

  • Multiple formulation agar culture medium IVD

N/A - 00816576026258

Group A Beta Strep Agar, 15x100mm Plate, Reduced Stacking Ring, 17ml. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
GA72
In Commercial Distribution

  • 00816576026241 ()
  • 00816576026258 ()
GA72

  • Differential/selective agar culture medium IVD

N/A - 00816576026234

Columbia CNA Agar, 15x100mm Plate, 19ml (reduced stacking ring). Hardy Diagnostics Columbia CNA Agar is recommended for use as a selective growth medium for the isolation and differentiation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora.
HARDY DIAGNOSTICS
GA50
In Commercial Distribution

  • 00816576026227 ()
  • 00816576026234 ()
GA50

  • Differential/selective agar culture medium IVD

N/A - 00816576026210

MacConkey Agar, 15x100mm Plate, 19ml (reduced stacking ring). 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
GA35
In Commercial Distribution

  • 00816576026203 ()
  • 00816576026210 ()
GA35

  • Differential/selective agar culture medium IVD
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