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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"MGB Alert® VZV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ORF 38 region of VZV(Varicella-Zoster Virus). The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Elitechgroup Mdx LLC
800419
In Commercial Distribution

  • 03661540951527 ()
800419

  • Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® HSV Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of one probe at 4.96 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
800349
In Commercial Distribution

  • 03661540951367 ()
800349

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® Enterovirus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Enterovirus. The mix consists of one probe at 0.14 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
800337
In Commercial Distribution

  • 03661540951329 ()
800337

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
"MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. "
Elitechgroup Mdx LLC
800335
In Commercial Distribution

  • 03661540951305 ()
800335

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® hMPV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from hMPV (human Metapneumovirus). The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm"
Elitechgroup Mdx LLC
800307
In Commercial Distribution

  • 03661540951268 ()
800307

  • Human metapneumovirus (hMPV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Parvovirus B19 Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP1 Capsid Protein (VP1u) gene region of Parvovirus B19. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm."
Elitechgroup Mdx LLC
M800683
In Commercial Distribution

  • 03661540951183 ()
M800683

  • Parvovirus B19 nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Parvovirus B19 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Parvovirus B19. The mix consists of a total of 4.50 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 88 bp nucleic acid sequence from the VP1 Capsid Protein (VP1u) gene region of Parvovirus B19.
Elitechgroup Mdx LLC
M800682
In Commercial Distribution

  • 03661540951176 ()
M800682

  • Parvovirus B19 nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® JC Virus Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP2 Tantigen region of JC Virus. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm."
Elitechgroup Mdx LLC
M800602
In Commercial Distribution

  • 03661540950360 ()
M800602

  • JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV8 Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ORF26 gene region in HHV8. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm."
Elitechgroup Mdx LLC
M800598
In Commercial Distribution

  • 03661540950308 ()
M800598

  • Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)
10 gr Syringe, 15 Mixing Tips. Resiment Ready Mix with Fluoride is a high-performance dental resin cement designed for the final cementation of crowns, bridges, implants, and inlays.
STERNGOLD DENTAL LLC
RRM-FL
In Commercial Distribution

  • 00841549118265 ()


  • Dental composite resin
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