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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DSQ Alert Enterovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 14.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 138 bp region of the 5’-UTR of enterovirus.
Elitechgroup Mdx LLC
M800708
In Commercial Distribution

  • 03661540952104 ()
M800708

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2."
Elitechgroup Mdx LLC
800518
In Commercial Distribution

  • 03661540951688 ()
800518

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 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. 25 vials; each 480 reactions.
ELITECH GROUP INC.
800333-25
In Commercial Distribution

  • 03661540952289 ()
800333-25

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 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. QTY 100 vials @ 480 reactions each.
ELITECH GROUP INC.
800333-100
In Commercial Distribution

  • 03661540952180 ()
800333-100

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert Enterovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 0.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm.
Elitechgroup Mdx LLC
M800709
In Commercial Distribution

  • 03661540952111 ()
M800709

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
MGB Alert HSV-2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the glycoprotein-G gene of HSV-2. The mix consists of a total of 1.44 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
M800588
In Commercial Distribution

  • 03661540952036 ()
M800588

  • Herpes simplex virus 2 (HSV2) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert HSV-1 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the glycoprotein-D gene of HSV-1. The mix consists of a total of 1.44 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with AquaPhluor 593 and has an excitation wavelength maxima of 593 nm and an emission wavelength maxima of 613 nm.
Elitechgroup Mdx LLC
M800586
In Commercial Distribution

  • 03661540952012 ()
M800586

  • Herpes simplex virus 1 (HSV1) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from CMV (Cytomegalovirus). 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
800423
In Commercial Distribution

  • 03661540951541 ()
800423

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from CMV (Cytomegalovirus). 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
800404
In Commercial Distribution

  • 03661540951459 ()
800404

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrA gene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 and has an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm"
Elitechgroup Mdx LLC
M800687
In Commercial Distribution

  • 03661540951220 ()
M800687

  • Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT)
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