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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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AnaeroGRO - 00816576024520

LKV Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ LKV (Laked Blood with Kanamycin and Vancomycin) Agar is recommended for use in the selective isolation and partial identification of obligately anaerobic gram-negative bacilli, such as Prevotella spp. and Bacteroides spp.
HARDY DIAGNOSTICS
AG601
Not in Commercial Distribution

  • 00816576024520 ()
AG601

  • Differential/selective agar culture medium IVD

AnaeroGRO - 00816576024391

Bacteroides Bile Esculin Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selective, and differential medium recommended for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila spp.
HARDY DIAGNOSTICS
AG051
Not in Commercial Distribution

  • 00816576024391 ()
AG051

  • Differential/selective agar culture medium IVD

N/A - 00816576024230

Selective Strep Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Selective Strep Agar is a selective medium recommended for use in the primary isolation of all Streptococcus species, including streptococcal groups A (S. pyogenes), B (S. agalactiae), C, D, F, G, and S. pneumoniae, especially from repiratory specimens.
HARDY DIAGNOSTICS
A70
In Commercial Distribution

  • 00816576024223 ()
  • 00816576024230 ()
A70

  • Differential/selective agar culture medium IVD

HardyCHROM - 10819398028421

HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromogenic medium recommended for the selective isolation and differentiation of Cronobacter (Enterobacter) sakazakii from other members of the family Enterobacteriaceae based on colony color.
HARDY DIAGNOSTICS
G315
Not in Commercial Distribution

  • 00819398028424 ()
  • 10819398028421 ()
G315

  • Differential/selective agar culture medium IVD

Strep B Carrot Broth™ - 00819398028530

Strep B Carrot Broth™ One-Step, for the detection of hemolytic Group B Strep in pregnant women, no reaction tile required, 16x100mm tube, 6ml fill, compatible with BD Innova®, 100 tubes per box Strep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimens collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of hemolytic GBS.
HARDY DIAGNOSTICS
Z46BX
In Commercial Distribution

  • 00819398028516 ()
  • 00819398028530 ()
Z46BX

  • Differential/selective broth culture medium IVD

Strep B Carrot Broth™ - 00819398028523

Strep B Carrot Broth™ One-Step, for the detection of hemolytic Group B Strep in pregnant women, no reaction tile required, 12x80mm plastic tube, compatible with the WASP® instrument, 100 tubes per box Strep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimens collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of hemolytic GBS.
HARDY DIAGNOSTICS
Z44BX
In Commercial Distribution

  • 00819398028509 ()
  • 00819398028523 ()
Z44BX

  • Differential/selective broth culture medium IVD

N/A - 00819398026499

Strep B Carrot Broth™ One-Step, 13x100mm Tube, 4ml Strep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women.
HARDY DIAGNOSTICS
Z40
In Commercial Distribution

  • 00819398026482 ()
  • 00819398026499 ()
Z40

  • Differential/selective broth culture medium IVD

Carrot Broth™ - 10819398020579

Strep B Carrot Broth™ Tiles, for the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tiles must be added to broth (not included) upon inoculation.
HARDY DIAGNOSTICS
Z140T
In Commercial Distribution

  • 10819398020579 ()
  • 00819398020572 ()
Z140T

  • Differential/selective broth culture medium IVD

N/A - 00816576023608

CLED / Mueller Hinton, 15x100, Biplate, 10/pk For the isolation, enumeration, and presumptive identification of urinary pathogens Section I: CLED (Cystine Lactose Electrolyte Deficient) Section II: Mueller Hinton
HARDY DIAGNOSTICS
2051
Not in Commercial Distribution

  • 00816576023592 ()
  • 00816576023608 ()
2051

  • Multiple formulation agar culture medium IVD

HardyCHROM - 00816576026807

HardyCHROM™ MRSA/ HardyCHROM™ Staph aureus, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ MRSA is a selective and differential chromogenic medium recommended for the qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings. HardyCHROM™ Staph aureus is a chromogenic medium recommended for the isolation, differentiation, and enumeration of Staphylococcus aureus by colony color
HARDY DIAGNOSTICS
J35
In Commercial Distribution

  • 00816576026791 ()
  • 00816576026807 ()
J35

  • Multiple formulation agar culture medium IVD
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