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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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OXOID LIMITED
DR0702G
In Commercial Distribution

  • 05032384519842 ()


  • Beta-haemolytic Streptococcus serological grouping IVD, reagent
Reference strain
Ssi Diagnostica A/S
84898
In Commercial Distribution

  • 05713106848982 ()
84898

  • Multiple Streptococcus species antigen IVD, control
SET ZZ BASE BB-MA-WSM B (White Scanmarker and screw). The ZZ BASE WSM (WHITE SCANMARKER) allows the user to record the implant position and inclination in the patient’s mouth or on the model.
ZIRKONZAHN SRL
ZBCD9431
In Commercial Distribution

  • D800ZBCD9431 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
4.0MM ISI CROWN AND BRIDGE PROSTHETIC KIT
OCO BIOMEDICAL INC
4.0MM ISI C&B PROSTHETIC KIT
In Commercial Distribution

  • D78540ICBPKF0 ()
4.0 I-CB PK (F)

  • Dental prosthesis/implant abutment screw analog, single-use
  • Dental implant analog
3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
OCO BIOMEDICAL INC
3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
In Commercial Distribution

  • D785325ICBPK0 ()
3.25 I-CB PK

  • Dental prosthesis/implant abutment screw analog, single-use
  • Dental implant analog
3.0MM CROWN & BRIDGE PROSTHETIC KIT
OCO BIOMEDICAL INC
3.0MM CROWN & BRIDGE PROSTHETIC KIT
In Commercial Distribution

  • D78530CBPK0 ()
3.0 CB-PK

  • Dental prosthesis/implant abutment screw analog, single-use
  • Dental implant analog
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™ 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
Bulk Ethyl Acetate used within Meridian's CON-Trate Stool Concentration Systems
MERIDIAN BIOSCIENCE, INC.
FK4318
In Commercial Distribution

  • 00840733102059 ()
FK4318

  • Faecal parasite isolation kit IVD
chromID® Strepto B agar is a selective chromogenic medium that is intended to aid in the qualitative determination of Group B Streptococcus (GBS) colonization in pregnant women
BIOMERIEUX SA
chromID® Strepto B agar
In Commercial Distribution

  • 03573026505684 ()
  • 03573026598075 ()
  • 03573026598082 ()


  • Differential/selective agar culture medium IVD
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