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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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VitaVitro - 06971982050397

No Description
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
Culture Oil, Oil-1.0, 60ml
In Commercial Distribution

  • 06971982050397 ()
V009060

  • IVF medium

Performa - 00885914077436

Performa Sonishield Antimicrobial Ultrasound Gel 8.5 oz
Performance Health Supply, LLC
081710748
Not in Commercial Distribution

  • 00885914077436 ()

  • Total Volume: 8.5 Fluid Ounce
081710748

  • Skin topical coupling gel

METRON - 00885914022023

METRON CLEAR ULTRASOUND GEL, 5L
Performance Health Supply, LLC
922099
Not in Commercial Distribution

  • 10885914022020 ()
  • 00885914022023 ()

  • Total Volume: 5 Liter
922099

  • Skin topical coupling gel

METRON - 00885914004050

METRON ULTRASOUND GEL, 5L
Performance Health Supply, LLC
303001
In Commercial Distribution

  • 10885914004057 ()
  • 00885914004050 ()

  • Total Volume: 5 Liter
303001

  • Skin topical coupling gel

DMEM Vitamines Stock 100x 1L - 05407010127126

No Description
Lonza Verviers
BE13-708Q
In Commercial Distribution

  • 05407010127126 ()
BE13-708Q

  • Ex vivo cell culture medium

CaseBioscience® - 07540161790035

CaseBio® Mineral Oil 100 mL
CaseBioscience Inc
MNOL-100
In Commercial Distribution

  • 07540161790035 ()

  • Total Volume: 100 Milliliter
MNOL-100

  • IVF medium

CaseBioscience® - 07540161790028

CaseBio® Viscous Oil 100 mL
CaseBioscience Inc
VSOL-100
In Commercial Distribution

  • 07540161790028 ()

  • Total Volume: 100 Milliliter
VSOL-100

  • IVF medium

N/A - 00819398028431

PEA w/SB/Tergitol 7 Agar 15x100 biplate, 10 plates per pack Differentiation and isolation of gram-negative and gram-positive organisms (as well as fermenting characteristics), preventing of Proteus swarming, differentiation of gram-positive organisms, early detector of yeast (growth on both PEA & T7 with white colonies).
HARDY DIAGNOSTICS
J120
In Commercial Distribution

  • 00819398028028 ()
  • 00819398028431 ()
J120

  • Multiple formulation agar culture medium IVD

N/A - 00816576028108

Blood Agar 5% / CLED Agar with Bile, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp.
HARDY DIAGNOSTICS
J65
In Commercial Distribution

  • 00816576028092 ()
  • 00816576028108 ()
J65

  • Multiple formulation agar culture medium IVD

N/A - 00816576027224

Blood Agar 5% / Group A Beta Strep Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
J92
Not in Commercial Distribution

  • 00816576027217 ()
  • 00816576027224 ()
J92

  • Multiple formulation agar culture medium IVD

N/A - 00816576027187

Brucella Agar with Hemin and Vitamin K /LKV (Laked Blood Kanamycin Vancomycin) Agar Biplate, 15x100 biplate, 10/pk For the cultivation of anaerobic bacteria and the selective isolation of Bacteroides spp.
HARDY DIAGNOSTICS
J67
In Commercial Distribution

  • 00816576027170 ()
  • 00816576027187 ()
J87

  • Multiple formulation agar culture medium IVD

N/A - 00816576026753

Blood Agar / CLED Agar / MacConkey Agar, 15x100mm Triplate, 7ml/section. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp. Hardy Diagnostics MacConkey Agar is recommended for use as a selective and differential medium for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens), on the basis of lactose fermentation.
HARDY DIAGNOSTICS
J315
In Commercial Distribution

  • 00816576026746 ()
  • 00816576026753 ()
J315

  • Multiple formulation agar culture medium IVD

N/A - 00816576026739

Blood Agar 5% / Eosin Methylene Blue (EMB), Levine Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens.
HARDY DIAGNOSTICS
J22
In Commercial Distribution

  • 00816576026722 ()
  • 00816576026739 ()
J22

  • Multiple formulation agar culture medium IVD

N/A - 00816576026654

V Agar / Starch Agar with Bromcresol Purple, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Starch Agar with Bromcresol Purple is recommended for use in the differentiation of Gardnerella vaginalis from genitourinary specimens. Hardy Diagnostics V Agar is an enriched media used for the isolation and differentiation of Gardnerella vaginalis.
HARDY DIAGNOSTICS
J181
Not in Commercial Distribution

  • 00816576026647 ()
  • 00816576026654 ()
J181

  • Multiple formulation agar culture medium IVD

N/A - 00816576026555

BluEcoli™ Urine Biplate, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics BluEcoli™ Urine Biplate is a urine culture media, consisting of Blood Agar on one side and BluEcoli™ Agar on the other side, which is used for the isolation of urinary pathogens and for the identification of E. coli.
HARDY DIAGNOSTICS
J123
In Commercial Distribution

  • 00816576026548 ()
  • 00816576026555 ()
J123

  • Multiple formulation agar culture medium IVD

HardyCHROM - 00816576026524

Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology.
HARDY DIAGNOSTICS
J119
In Commercial Distribution

  • 00816576026517 ()
  • 00816576026524 ()
J119

  • Multiple formulation agar culture medium IVD

AnaeroGRO - 00816576024490

MultiPak B, BRU with Hemin and Vitamin K, Monoplate; LKV, Monoplate; PEA, Monoplate. Hardy Diagnostics AnaeroGRO™ Brucella Agar with Hemin and Vitamin K is recommended for use in the primary isolation, quantitation, and partial identification of obligately anaerobic microorganisms from clinical specimens. This non-selective medium is also suitable for the growth of aerobic and microaerophilic bacteria when incubated under the appropriate conditions.
HARDY DIAGNOSTICS
AG313
In Commercial Distribution

  • 00816576024490 ()
AG313

  • Enriched agar culture medium IVD
  • Differential/selective agar culture medium IVD

PRAS Columbia Blood Agar (CA) - 00810048901166

AS-895 Columbia Blood Agar (CA) is intended for the isolation, quantitation, and partial identification of a variety of microorganisms, including fastidious organisms from clinical specimens. CA is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-895
In Commercial Distribution

  • 00810048902354 ()
  • 00810048901166 ()
AS-895

  • Enriched agar culture medium IVD

PRAS Yeast Casitone Fatty Acid Agar w/ Carbohydrates & Sheep Blood (YCFAC-B) - 00810048900473

AS-677 Yeast Casitone Fatty Acids Agar with Carbohydrates and Sheep Blood (YCFAC-B) is an enriched non-selective media for the cultivation of most anaerobic bacteria and other fastidious microorganisms, including Faecalibacterium prausnitzii. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque dark red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-677
In Commercial Distribution

  • 00810048901807 ()
  • 00810048900473 ()
AS-677

  • Enriched agar culture medium IVD

PRAS CDC Anaerobic Blood Agar (CDC) - 00810048900428

AS-646 CDC Anaerobic Blood Agar (CDC) is an enriched and differential media used for the growth and partial identification of obligate anaerobes. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque burgundy red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-646
In Commercial Distribution

  • 00810048901753 ()
  • 00810048900428 ()
AS-646

  • Enriched agar culture medium IVD
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