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.
Elitechgroup Mdx LLC
M800733
In Commercial Distribution

  • 03661540952326 ()


  • Nucleic acid amplification primer IVD
MGB Alert® BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800732
In Commercial Distribution

  • 03661540952319 ()


  • Nucleic acid amplification primer IVD
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)
"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)
Component 4 of 4 of A56124 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
A56519
In Commercial Distribution

  • 10190302019057 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
A56518
In Commercial Distribution

  • 10190302019019 ()
A56123

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
VPS Impression Material
DEN-MAT HOLDINGS, LLC
013386
In Commercial Distribution

  • 00359883006006 ()

  • Total Volume: 380 Milliliter
013386

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
013381
In Commercial Distribution

  • 00359883005993 ()

  • Total Volume: 380 Milliliter
013381

  • 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
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