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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® 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)
The MGB Alert Internal Control Set IC1-L 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 IC1-L 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
M800688
In Commercial Distribution

  • 03661540951237 ()
M800688

  • Exogenous DNA/RNA internal control IVD, kit
"MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrA gene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 and has an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm"
Elitechgroup Mdx LLC
M800687
In Commercial Distribution

  • 03661540951220 ()
M800687

  • Legionella species 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® Parvovirus B19 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Parvovirus B19. The mix consists of a total of 4.50 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 88 bp nucleic acid sequence from the VP1 Capsid Protein (VP1u) gene region of Parvovirus B19.
Elitechgroup Mdx LLC
M800682
In Commercial Distribution

  • 03661540951176 ()
M800682

  • Parvovirus B19 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)
The MGB Alert Internal Control Set IC2-8 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 IC2-8 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
M800600
In Commercial Distribution

  • 03661540950322 ()
M800600

  • Exogenous DNA/RNA internal control IVD, kit
"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)
"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)
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800599
In Commercial Distribution

  • 03661540950278 ()
M800599

  • Nucleic acid amplification mastermix kit IVD
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