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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VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012301
In Commercial Distribution

  • 07540172011013 ()

  • cartridge
  • Total Volume: 390 Milliliter
012301

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012386
In Commercial Distribution

  • 07540172017022 ()

  • Total Volume: 380 Milliliter
  • Cartridge
012385

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012381
In Commercial Distribution

  • 07540172017015 ()

  • Cartridge
  • Total Volume: 380 Milliliter
012380

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012385
In Commercial Distribution

  • 07540172000048 ()

  • Total Volume: 380 Milliliter
  • cartridge
012385

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012380
In Commercial Distribution

  • 07540172000031 ()

  • Total Volume: 380 Milliliter
  • cartridge
012380

  • Silicone dental impression material
The DSQ Alert IC2 Probe Mix contains a chemically synthesized DNA oligonucleotide probe designed to detect the IC2 nucleic acid sequence
Elitechgroup Mdx LLC
800741
In Commercial Distribution

  • 03661540952555 ()
800741

  • Exogenous DNA/RNA internal control IVD, kit
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. 30 Part B Carpules, bagged.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 67-028 N
In Commercial Distribution

  • D801SP67028N1 ()
67-028

  • Dentine adhesive
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody inactivated form. An initial high-temperature incubation step denatures the antibodies to activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM MgCl2 are provided for additional flexibility in optimizing reaction conditions.
Elitechgroup Mdx LLC
M800331
In Commercial Distribution

  • 03661540951787 ()
M800331

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody inactivated form. An initial high-temperature incubation step denatures the antibodies to activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM MgCl2 are provided for additional flexibility in optimizing reaction conditions.
Elitechgroup Mdx LLC
M800547
In Commercial Distribution

  • 03661540951725 ()
M800547

  • Nucleic acid amplification mastermix kit IVD
oncoReveal CDx Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.
Pillar Biosciences, Inc.
HDA-LC-2001-48-1
In Commercial Distribution

  • 00860001218220 ()
HDA-LC-2001-48-1

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
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