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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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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
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