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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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Nidacon - 07350025610191

An optimized staining technique for assessment of sperm vitality. For use with Assisted Reproduction Technology (ART)
Nidacon International AB
SpermVitalStain
In Commercial Distribution

  • 07350025610191 ()
SVS-010

  • Spermatozoa/semen motility medium supplement

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 - 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

InTray® PDA - B08812930

Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
BIO-MED DIAGNOSTICS, INC.
1293
In Commercial Distribution

  • B08812934 ()
  • B08812930 ()
  • B08812932 ()
21-293-001

  • Potato-dextrose fungal agar culture medium IVD

InTray® SAB - B08812630

A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approximately 5.6) is favorable for growth of fungi, especially yeasts and dermatophytes. Sabouraud's Dextrose Agar (SAB) is slightly inhibitory to contaminating bacteria in clinical specimens.
BIO-MED DIAGNOSTICS, INC.
1263
In Commercial Distribution

  • B08812634 ()
  • B08812630 ()
  • B08812632 ()
21-263-001

  • Basic/simple nutrient agar culture medium IVD

InTray® COLOREX Salmonella - B08812230

A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
BIO-MED DIAGNOSTICS, INC.
1223
In Commercial Distribution

  • B08812234 ()
  • B08812230 ()
  • B08812232 ()
21-223-001

  • Chromogenic Salmonella species agar culture medium IVD

InTray® COLOREX Yeast - B08811130

For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or genitourinary swabs.
BIO-MED DIAGNOSTICS, INC.
1113
In Commercial Distribution

  • B08811134 ()
  • B08811130 ()
  • B08811132 ()
21-113-001

  • Multiple Candida/yeast species culture isolate identification IVD, kit

InTray® COLOREX Screen - B08811030

For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
BIO-MED DIAGNOSTICS, INC.
1103
In Commercial Distribution

  • B08811034 ()
  • B08811030 ()
  • B08811032 ()
21-103-001

  • Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid

InPouch® TVC Subculture - B08810510

A highly selective growth medium which maintains viable Trichomonas vaginalis cultures (positive controls) for up to seven (7) days.
BIO-MED DIAGNOSTICS, INC.
1051
In Commercial Distribution

  • B08810510 ()
  • B08810513 ()
21-051-001

  • Differential/selective broth culture medium IVD

InTray® Mueller Hinton Chocolate Agar - B08824830

Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.
BIO-MED DIAGNOSTICS, INC.
2483
In Commercial Distribution

  • B08824834 ()
  • B08824830 ()
  • B08824832 ()
22-483-001

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

InTray® SAB+PVG - B088212730010

InTray SAB+PVG is for growth and observation of fungi, yeasts and dermatophytes. Inhibition is enhanced with the introduction of Polymyxin B, Vancomycin and Gentamicin.
BIO-MED DIAGNOSTICS, INC.
2127
In Commercial Distribution

  • B088212730010 ()


  • Multiple dermatophyte species culture isolate identification IVD, kit

InTray® DM - B08820630

An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
BIO-MED DIAGNOSTICS, INC.
2063
In Commercial Distribution

  • B08820630 ()
  • B08820634 ()
  • B08820632 ()
22-063-000

  • Multiple dermatophyte species culture isolate identification IVD, kit

Saline Solution (0.85%) - B08816120

Saline Solution (0.85%) is a saline solution for viral specimens.
BIO-MED DIAGNOSTICS, INC.
1612
In Commercial Distribution

  • B08816120 ()
  • B08816121 ()
  • B08816122 ()
11-612-001

  • Saline suspension medium/diluent IVD

InTray DM-FungID - B08815930

InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.
BIO-MED DIAGNOSTICS, INC.
1593
In Commercial Distribution

  • B08815934 ()
  • B08815930 ()
  • B08815932 ()
21-593-001

  • Multiple dermatophyte species culture isolate identification IVD, kit

InTray® BHI - B08815030

Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds.
BIO-MED DIAGNOSTICS, INC.
1503
In Commercial Distribution

  • B08815034 ()
  • B08815030 ()
  • B08815032 ()
21-503-001

  • Basic/simple nutrient agar culture medium IVD

InTray® XLT4 - B08814930

A medium devised for selection of non-typhi Salmonella from samples contaminated with fecal matter. Growth of other organisms is inhibited and Salmonella can be differentiated from other organisms by colony color.
BIO-MED DIAGNOSTICS, INC.
1493
In Commercial Distribution

  • B08814934 ()
  • B08814930 ()
  • B08814932 ()
21-493-001

  • Salmonella/Shigella species agar culture medium IVD

InTray® Brilliant Green - B08814630

Highly selective medium for the isolation of Salmonella other than S. typhi from feces and other materials.
BIO-MED DIAGNOSTICS, INC.
1463
In Commercial Distribution

  • B08814634 ()
  • B08814630 ()
  • B08814632 ()
21-463-001

  • MLCB Salmonella species agar culture medium IVD

InTray® TSA - B08814430

A non-selective medium used for isolation, cultivation and enumeration of non-fastidious and fastidious microorganisms. The device is designed to interface directly with standard methods for bacterial testing of water samples using the Membrane Filter (MF) Technique.
BIO-MED DIAGNOSTICS, INC.
1443
In Commercial Distribution

  • B08814434 ()
  • B08814430 ()
  • B08814432 ()
21-443-001

  • Basic/simple nutrient agar culture medium IVD

InTray® SMA - B08814230

a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar."
BIO-MED DIAGNOSTICS, INC.
1423
In Commercial Distribution

  • B08814234 ()
  • B08814230 ()
  • B08814232 ()
21-423-001

  • Sorbitol-MacConkey E. coli agar culture medium IVD

InTray® Malt Extract Agar - B08813330

A nutrient-rich medium for the use of cultivation, isolation and enumeration of a broad-spectrum of environmental and pathogenic yeasts and molds. The device can accept samples by direct plating or interface directly with standard methods for microbial testing of water samples using the Membrane Filter (MF) Technique1. The acidic pH of Malt Extract Agar allows for the optimal growth of molds and yeasts while restricting bacterial growth.
BIO-MED DIAGNOSTICS, INC.
1333
In Commercial Distribution

  • B08813334 ()
  • B08813330 ()
  • B08813332 ()
21-333-001

  • Malt extract agar culture medium IVD

InTray® MSA - B08813030

Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumeration of staphylococci from clinical/non-clinical materials. A change of the phenol red indicator (Mannitol fermentation) aids in differentiating staphylococci species.
BIO-MED DIAGNOSTICS, INC.
1303
In Commercial Distribution

  • B08813034 ()
  • B08813030 ()
  • B08813032 ()
21-303-001

  • Mannitol-salt Staphylococcus species agar culture medium IVD
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