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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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
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)
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 00812125010051 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 10812125010058 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 10.0 mL bottle for approximately 1000 tests
Supertechs, Inc.
6100D
In Commercial Distribution

  • B7826100D03 ()
6100D

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 0.5 mL vial for approximately 50 tests
Supertechs, Inc.
6100A
In Commercial Distribution

  • B7826100A00 ()
6100

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
BD MAX™ CT/GC/TV Contains: 24 each, Master Mix, Extraction Tubes, Septum Caps, Strips-Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
BECTON, DICKINSON AND COMPANY
442970
Not in Commercial Distribution

  • 00382904429706 ()
442970

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Tropical Mix Colors b condoms
In Commercial Distribution

  • 00850281004385 ()
  • 00850281004583 ()


  • Basic male condom, Hevea-latex
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