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® HSV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 141 nucleic acid sequence from the glycoprotein D region of HSV
Elitechgroup Mdx LLC
800348
In Commercial Distribution

  • 03661540951350 ()
800348

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
"MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV."
Elitechgroup Mdx LLC
800334
In Commercial Distribution

  • 03661540951299 ()
800334

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Pan Legionella Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Legionella micadadei. The mix consists of a total of 9.00 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 105 bp nucleic acid sequence from the ssrA gene region of Legionella micdadei."
Elitechgroup Mdx LLC
M800686
In Commercial Distribution

  • 03661540951213 ()
M800686

  • Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® JC Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from JC Virus. The mix consists of a total of 6.48 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 78 bp nucleic acid sequence from the VP2 Tantigen region of JC Virus"
Elitechgroup Mdx LLC
M800601
In Commercial Distribution

  • 03661540950346 ()
M800601

  • JC virus (JCV) 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
In Commercial Distribution

  • 03661540950223 ()
M800583

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
Caulk® Post & Core Kit
DENTSPLY INTERNATIONAL INC.
61i000
Not in Commercial Distribution

  • D00261I0001 ()

  • 15 Fiber Posts 2 Reamers 4 Drills 1 TCGel, 25 Tips, 1 bottle adhesive & activator 1 Mixing Well 2 syringes FluoroCore 10 Mix Tips and Endo Intraoral Tips 1 Mix Pad 30 Paper Points 50 Root Canal Tips
61i000

  • Crown surgical drill bit, reusable
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)
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
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