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 Class Implantable

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"MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV."
Elitechgroup Mdx LLC
800414
In Commercial Distribution

  • 03661540951480 ()
800414

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV."
Elitechgroup Mdx LLC
800334
In Commercial Distribution

  • 03661540951299 ()
800334

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® HSV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 141 nucleic acid sequence from the glycoprotein D region of HSV
Elitechgroup Mdx LLC
800348
In Commercial Distribution

  • 03661540951350 ()
800348

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
"MGB Alert® Pan Legionella Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Legionella micadadei. The mix consists of a total of 9.00 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 105 bp nucleic acid sequence from the ssrA gene region of Legionella micdadei."
Elitechgroup Mdx LLC
M800686
In Commercial Distribution

  • 03661540951213 ()
M800686

  • Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® JC Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from JC Virus. The mix consists of a total of 6.48 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 78 bp nucleic acid sequence from the VP2 Tantigen region of JC Virus"
Elitechgroup Mdx LLC
M800601
In Commercial Distribution

  • 03661540950346 ()
M800601

  • JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Trichomonas vaginalis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Trichomonas vaginalis. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 67 bp nucleic acid sequence from a repeated DNA fragment in Trichomonas vaginalis."
Elitechgroup Mdx LLC
M800583
In Commercial Distribution

  • 03661540950223 ()
M800583

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the major capsid protein VP1 gene of the BK Virus. The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800727
In Commercial Distribution

  • 03661540952753 ()


  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"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)
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