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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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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
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
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
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
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
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
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
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
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
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
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