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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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ACU-SABOURAUD - 10814105021221

ACU-SABOURAUD, 24/Bx
ACUDERM, INC.
M103
In Commercial Distribution

  • 00814105021224 ()
  • 10814105021221 ()


  • Dextrose utilization microbial reagent IVD

ACU-DTM - 10814105021214

ACU-DTM, Dermatophyte Test Medium, 24/bX
ACUDERM, INC.
M101
In Commercial Distribution

  • 00814105021217 ()
  • 10814105021214 ()


  • Multiple dermatophyte species culture isolate identification IVD, kit

ACU-DTM - 10814105021207

ACU-DTM, Dermatophyte Test Medium, 24/bX
ACUDERM, INC.
M101
In Commercial Distribution

  • 00814105021200 ()
  • 10814105021207 ()


  • Multiple dermatophyte species culture isolate identification IVD, kit

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

Select - 03610520034309

CandiSelect
BIO-RAD
63740
In Commercial Distribution

  • 03610520034309 ()

  • 20 x Diam 90mm
63740

  • Differential/selective agar culture medium IVD

Select - 03610520002919

UriSelect 4
BIO-RAD
63727
In Commercial Distribution

  • 03610520002919 ()

  • 100 x 90 mm
63727

  • Differential/selective agar culture medium IVD

Select - 03610520002940

SaSelect
BIO-RAD
63748
In Commercial Distribution

  • 03610520002940 ()

  • 20 x Diam 90mm
63748

  • Differential/selective agar culture medium IVD

Select - 03610520002902

UriSelect 4
BIO-RAD
63726
In Commercial Distribution

  • 03610520002902 ()

  • 20 x Diam 90mm
63726

  • Differential/selective agar culture medium IVD

Remel - 00842558108605

SPECTRA Strep A Agar 10/PK
REMEL, INC.
R01812
In Commercial Distribution

  • 30842558108606 ()
  • 00842558108605 ()


  • Differential/selective agar culture medium IVD

Northeast Laboratory Services - 00810144911328

Purple Broth Base w/ Durham Tube & Mannitol
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144911328 ()
T3019

  • Basic/simple nutrient broth culture medium IVD
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