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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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Mohs Mouse/Rabbit PolyDetector DAB HRP Brown - B502BSB0307S0

The Mohs Mouse/Rabbit PolyDetector HRP Brown Detection System is a 1-step Fab micropolymeric detection system that allows for the demonstration of antigens in cryostat sections, formalin-fixed paraffin-embedded tissue, and cell preparations.
BIO SB, INC.
BSB 0307S
In Commercial Distribution

  • B502BSB0307S0 ()

  • Total Volume: 5 Milliliter
BSB 0307S

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

Diversatek Healthcare - 00816734022108

Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
PHNS-P
In Commercial Distribution

  • 00816734022108 ()
  • B019PHNSP0 ()

  • Catheter Gauge: 5 French
PHNS-P

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022054

Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
DIVERSATEK HEALTHCARE, INC.
PHN10-P
In Commercial Distribution

  • 00816734022054 ()
  • B019PHN10P0 ()

  • Catheter Gauge: 5 French
PHN10-P

  • Manometric gastrointestinal motility analysis system

MAR0Fuse - M896MAR0FUSE5CC1

MAR0Fuse Demineralized Bone Matrix Gel
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse5cc
Not in Commercial Distribution

  • M896MAR0FUSE5CC1 ()

  • Total Volume: 5 Milliliter


  • Bone matrix implant, human-derived

VOLATILES LEVEL 1 - B800VOL1V2SFRIH0

VOLATILES LEVEL 1
UTAK LABORATORIES, INC.
VOL 1 V2 S F RIH
In Commercial Distribution

  • B800VOL1V2SFRIH5 ()
  • B800VOL1V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 1 V2 S F RIH

  • Multiple drugs of abuse IVD, control

VOLATILES 12.5 MG/DL - B800VOL125MMC0

VOLATILES 12.5 MG/DL
UTAK LABORATORIES, INC.
VOL 12.5 MMC
In Commercial Distribution

  • B800VOL125MMC5 ()
  • B800VOL125MMC0 ()

  • Total Volume: 5 Milliliter
VOL 12.5 MMC

  • Multiple drugs of abuse IVD, control

VITAMINS LEVEL 3 - B800VITL3SMAYO0

VITAMINS LEVEL 3
UTAK LABORATORIES, INC.
VIT L3 S MAYO
In Commercial Distribution

  • B800VITL3SMAYO5 ()
  • B800VITL3SMAYO0 ()

  • Total Volume: 5 Milliliter
VIT L3 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control

VITAMINS LEVEL 2 - B800VITL2SMAYO0

VITAMINS LEVEL 2
UTAK LABORATORIES, INC.
VIT L2 S MAYO
In Commercial Distribution

  • B800VITL2SMAYO5 ()
  • B800VITL2SMAYO0 ()

  • Total Volume: 5 Milliliter
VIT L2 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control

VITAMINS LEVEL 1 - B800VITL1SMAYO0

VITAMINS LEVEL 1
UTAK LABORATORIES, INC.
VIT L1 S MAYO
In Commercial Distribution

  • B800VITL1SMAYO5 ()
  • B800VITL1SMAYO0 ()

  • Total Volume: 5 Milliliter
VIT L1 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control

VITAMIN D PLUS - B800VITDSWMUSM0

VITAMIN D PLUS
UTAK LABORATORIES, INC.
VIT D S WMUSM
In Commercial Distribution

  • B800VITDSWMUSM5 ()
  • B800VITDSWMUSM0 ()

  • Total Volume: 5 Milliliter
VIT D S WMUSM

  • Multiple form 25-hydroxy Vitamin D IVD, control
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