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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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The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans. Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
BIO-MED DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • B08816026 ()
  • B08816020 ()
  • B08816021 ()
11-602-001

  • Viral transport medium IVD
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
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
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
Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD
O-Mask Oxygen Mask, Child
B.L.S. Systems Limited
6210
In Commercial Distribution

  • B00262107 ()
  • B00262100 ()
  • B00262109 ()

  • Child
6210

  • Non-rebreathing oxygen face mask
Rescuer Flo2Max Oxygen Mask with Universal Tubing, Large Adult
B.L.S. Systems Limited
6100
In Commercial Distribution

  • B0026100U7 ()
  • B0026100U0 ()
  • B0026100U9 ()

  • Large Adult
6100-U

  • Non-rebreathing oxygen face mask
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