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® JC Virus Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP2 Tantigen region of JC Virus. The mix consists of one probe at 0.72 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
M800602
In Commercial Distribution

  • 03661540950360 ()
M800602

  • JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV8 Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ORF26 gene region in HHV8. The mix consists of one probe at 0.72 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
M800598
In Commercial Distribution

  • 03661540950308 ()
M800598

  • Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013306
In Commercial Distribution

  • 07540172011044 ()

  • cartridge
  • Total Volume: 390 Milliliter
013306

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013301
In Commercial Distribution

  • 07540172011037 ()

  • cartridge
  • Total Volume: 390 Milliliter
013301

  • 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). QTY-100@ 480reactions.
ELITECH GROUP INC.
800350-100
In Commercial Distribution

  • 03661540952203 ()
800350-100

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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). QTY-25@ 480reactions.
ELITECH GROUP INC.
800350-25
In Commercial Distribution

  • 03661540952197 ()
800350-25

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
FluoroCore® Starter Pack
DENTSPLY INTERNATIONAL INC.
612310
Not in Commercial Distribution

  • D0026123101 ()

  • Weight: 4.5 Gram
  • 1 syringe base, 1 syringe catalyst, P&B NT (2mL), Self Cure Activator (2mL), Brushes, Mix Tray, and accessories
612310

  • Dental composite resin
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-5135
In Commercial Distribution

  • 05060169691070 ()


  • Progesterone IVD, calibrator
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-5130
In Commercial Distribution

  • 05060169690882 ()


  • Progesterone IVD, control
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. QTY 100; 480 reactions each.
ELITECH GROUP INC.
800332-100
In Commercial Distribution

  • 03661540952173 ()
800332-100

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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