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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Trichophyton Agar #2, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C52
In Commercial Distribution

  • 00819398020367 ()
  • 00819398020374 ()
C52

  • Differential/selective agar culture medium IVD
Trichophyton Agar #1, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C51
In Commercial Distribution

  • 00819398020343 ()
  • 00819398020350 ()
C51

  • Differential/selective agar culture medium IVD
Middlebrook 7H11 Select Slant, 20x125 tube, 100 tubes/box (Mitchison formula with CAPT antibiotics) For selective isolation of Mycobacterium spp.
HARDY DIAGNOSTICS
C38BX
In Commercial Distribution

  • 00819398020305 ()
  • 00819398020312 ()
C38BX

  • Differential/selective agar culture medium IVD
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 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™ 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
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
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
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
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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