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® HHV-6 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HHV-6 (Human Herpesvirus 6). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 115 nucleic acid sequence from the U67 gene region of HHV-6. "
Elitechgroup Mdx LLC
800338
In Commercial Distribution

  • 03661540951336 ()
800338

  • Human herpesvirus 6 (HHV6) 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.
Elitechgroup Mdx LLC
800421-am
In Commercial Distribution

  • 03661540950117 ()
800421-am

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from BK Virus. The mix consists of a total of 2.6 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 72 nucleic acid sequence from the VP1 region of BK Virus.
Elitechgroup Mdx LLC
800411-am
In Commercial Distribution

  • 03661540950100 ()
800411-am

  • BK virus (BKV) 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-am
In Commercial Distribution

  • 03661540950230 ()
M800583-am

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect a repeated DNA fragment in Trichomonas vaginalis. 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 and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
M800582-am
In Commercial Distribution

  • 03661540950216 ()
M800582-am

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
2x60g cart.,12 mix&12 oral tips. Precision automix low viscosity polyvinyl siloxane impression material for crown, bridge, implant prosthetics, inlay and only impressions.
STERNGOLD DENTAL LLC
220101
In Commercial Distribution

  • 00841549115912 ()


  • Silicone dental impression material
Aquasil® Ultra+ Regular Set Kit
DENTSPLY INTERNATIONAL INC.
678699
In Commercial Distribution

  • D0026786990 ()

  • 5 Cartridges (50mL), 12 mix tips, 6 I/O tips; 4 small digit (1.6mL) cartridges, 2 large digit (2.4mL) cartridges, 1 syringe dispenser, 6 digit Mix Tips, 6 I/O tips, 1 bottle adhesive (14mL)
678699

  • Silicone dental impression material
"MGB Alert® Enterovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Enterovirus. The mix consists of a total of 1.4 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the 5’-UTR region of Enterovirus."
Elitechgroup Mdx LLC
800336
In Commercial Distribution

  • 03661540951312 ()
800336

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
Aquasil® Ultra+ digit® LV/XLV Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678033
In Commercial Distribution

  • D0026780331 ()

  • Total Volume: 1.6 Milliliter
  • 4 (1.6mL) small cartridges, 2 (2.4mL) large cartridges, 6 mix tips, 6 intraoral tips, 1 syringe dispenser
  • Total Volume: 2.4 Milliliter
678033

  • Silicone dental impression material
"MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 region of CMV (Cytomegalovirus). "
Elitechgroup Mdx LLC
800413
In Commercial Distribution

  • 03661540951473 ()
800413

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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