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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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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
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST7001-2
In Commercial Distribution

  • 86974541564355 ()
  • 06974541564366 ()


  • General specimen collection kit IVD, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST7001-2
In Commercial Distribution

  • 86974541564355 ()
  • 06974541564359 ()


  • General specimen collection kit IVD, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST7001-1
In Commercial Distribution

  • 86974541564331 ()
  • 06974541564342 ()


  • General specimen collection kit IVD, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST7001-1
In Commercial Distribution

  • 86974541564355 ()
  • 06974541564335 ()


  • General specimen collection kit IVD, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST9001-1
In Commercial Distribution

  • 86974541563143 ()
  • 06974541563154 ()


  • General specimen collection kit IVD, clinical
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