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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® Adenovirus Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the hexon gene, which is present in all known Adenovirus types. The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
800498
In Commercial Distribution

  • 03661540951671 ()
800498

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus. The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all known Adenovirus types.
Elitechgroup Mdx LLC
800497
In Commercial Distribution

  • 03661540951664 ()
800497

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert Internal Control Set IC2-H 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-H 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
800496
In Commercial Distribution

  • 03661540951657 ()
800496

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC1-A 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-A 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
800495
In Commercial Distribution

  • 03661540951640 ()
800495

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC1-V 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-V 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
800439
In Commercial Distribution

  • 03661540951633 ()
800439

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC2-C 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-C 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
800432
In Commercial Distribution

  • 03661540951626 ()
800432

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC2-C 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-C 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
800431
In Commercial Distribution

  • 03661540951619 ()
800431

  • Exogenous DNA/RNA internal control IVD, kit
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
800430
In Commercial Distribution

  • 03661540951602 ()
800430

  • 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
800429
In Commercial Distribution

  • 03661540951596 ()
800429

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC1 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 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
800427
In Commercial Distribution

  • 03661540951589 ()
800427

  • Exogenous DNA/RNA internal control IVD, kit
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