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® 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.
Elitechgroup Mdx LLC
M800727
In Commercial Distribution

  • 03661540952357 ()


  • Nucleic acid amplification primer IVD
"MGB Alert® HHV-6 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HHV-6. 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
800425
In Commercial Distribution

  • 03661540951565 ()
800425

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV-6 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HHV-6. 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
800339
In Commercial Distribution

  • 03661540951343 ()
800339

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)
"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)
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013386
In Commercial Distribution

  • 07540172017046 ()

  • Cartridge
  • Total Volume: 380 Milliliter
013385

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013381
In Commercial Distribution

  • 07540172017039 ()

  • Cartridge
  • Total Volume: 380 Milliliter
013380

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013385
In Commercial Distribution

  • 07540172000147 ()

  • Total Volume: 380 Milliliter
  • cartridge
013385

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013380
In Commercial Distribution

  • 07540172000130 ()

  • Total Volume: 380 Milliliter
  • cartridge
013380

  • Silicone dental impression material
"MGB Alert® VZV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from VZV (VaricellaZoster Virus). The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the VZV sequence within the ORF 38 region."
Elitechgroup Mdx LLC
800418
In Commercial Distribution

  • 03661540951510 ()
800418

  • Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus. The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all known Adenovirus types.
Elitechgroup Mdx LLC
800497
In Commercial Distribution

  • 03661540951664 ()
800497

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
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