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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 1 & 2 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Elitechgroup Mdx LLC
800416
In Commercial Distribution

  • 03661540951503 ()
800416

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
"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 2.4 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
800415
In Commercial Distribution

  • 03661540951497 ()
800415

  • Human herpesvirus 6 (HHV6) 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). "
Elitechgroup Mdx LLC
800413
In Commercial Distribution

  • 03661540951473 ()
800413

  • 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® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from CMV (Cytomegalovirus). 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
800404
In Commercial Distribution

  • 03661540951459 ()
800404

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert Internal Control Set MS2-E consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set MS2-E can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800365
In Commercial Distribution

  • 03661540951442 ()
800365

  • Exogenous RNA internal control kit IVD
The MGB Alert Internal Control Set MS2-M consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set MS2-M can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800364
In Commercial Distribution

  • 03661540951435 ()
800364

  • Exogenous RNA internal control kit IVD
The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-B can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800363
In Commercial Distribution

  • 03661540951428 ()
800363

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800362
In Commercial Distribution

  • 03661540951411 ()
800362

  • Exogenous DNA/RNA internal control IVD, kit
MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye 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
800355
In Commercial Distribution

  • 03661540951398 ()
800355

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
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