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® 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
800350
In Commercial Distribution

  • 03661540951374 ()
800350

  • Cytomegalovirus (CMV) 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
In Commercial Distribution

  • 03661540951466 ()


  • 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
800332
In Commercial Distribution

  • 03661540951275 ()
800332

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® hMPV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from hMPV (human Metapneumovirus). The mix consists of a total of 8.4 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 186 nucleic acid sequence from the Polymerase (L) gene of hMPV."
Elitechgroup Mdx LLC
800306
In Commercial Distribution

  • 03661540951251 ()
800306

  • Human metapneumovirus (hMPV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV8 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HHV8. The mix consists of a total of 8.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 109 bp nucleic acid sequence from the ORF26 gene region in HHV8."
Elitechgroup Mdx LLC
M800597
In Commercial Distribution

  • 03661540950285 ()
M800597

  • Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)
"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
800414
In Commercial Distribution

  • 03661540951480 ()
800414

  • Epstein-Barr virus (EBV) 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. QTY 25 @ 480 reactions.
ELITECH GROUP INC.
800332-25
In Commercial Distribution

  • 03661540952272 ()
800332-25

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV-6 2.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Human herpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of a total of 2.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a region of the U67 gene."
Elitechgroup Mdx LLC
800499
In Commercial Distribution

  • 03661540951978 ()
800499

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
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