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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 Class Implantable

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N/A - 00819398020015

Nitrate Broth, 6mL, 15x103mm tube, 20 tubes/box For the determination of nitrate reduction and gas production of bacteria. Contains a durham tube.
HARDY DIAGNOSTICS
K42
In Commercial Distribution

  • 00819398020008 ()
  • 00819398020015 ()
K42

  • Differential/selective broth culture medium IVD

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
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