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® HHV-6 2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from the U67 gene of Human herpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of one probe at 0.56 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. "
Elitechgroup Mdx LLC
800500
In Commercial Distribution

  • 03661540951985 ()
800500

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the Major Outer Membrane protein gene region of Chlamydophila pneumoniae. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with fluorescein (FAM) and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
800434
In Commercial Distribution

  • 03661540951770 ()
800434

  • Chlamydia pneumoniae nucleic acid 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® 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)
"MGB Alert® Legionella pneumophila Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the macrophage infectivity potentiator (mip) gene region of Legionella pneumophila. The mix consists of one probe at 1.44 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
M800685
In Commercial Distribution

  • 03661540951206 ()
M800685

  • Legionella pneumophila nucleic acid IVD, kit, nucleic acid technique (NAT)
T-MIXER MIXING TIPS (20/pack) Ratio: 1:1, Type: Brown Short; For more information: https://www.scottsdental.com/catalog/product/view/id/23796/s/t-mixer-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8186
In Commercial Distribution

  • D77810481860 ()
  • D77810481861 ()
104-8186

  • Dental material mixing nozzle
T-MIXER MIXING TIPS (20/pack) Ratio: 1:1, Type: Brown Taper; For more information: https://www.scottsdental.com/catalog/product/view/id/23796/s/t-mixer-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8183
In Commercial Distribution

  • D77810481830 ()
  • D77810481831 ()
104-8183

  • Dental material mixing nozzle
BROWN HUB MIXING TIPS (20/pack) Ratio: 1:1; For more information: https://www.scottsdental.com/catalog/product/view/id/17353/s/temporary-cement-handheld-automix-syringe-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8175
In Commercial Distribution

  • D77810481750 ()
  • D77810481751 ()
104-8175

  • Dental material mixing nozzle
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