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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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The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800738
In Commercial Distribution

  • 03661540952401 ()


  • Nucleic acid amplification primer IVD
The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800737
In Commercial Distribution

  • 03661540952395 ()


  • Nucleic acid amplification primer IVD
The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC1 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800736
In Commercial Distribution

  • 03661540952388 ()
M800736

  • Nucleic acid amplification primer IVD
The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an un-assayed 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.
ELITECH GROUP INC.
M800735
In Commercial Distribution

  • 03661540952371 ()


  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB Alert IC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays.
Elitechgroup Mdx LLC
M800728
In Commercial Distribution

  • 03661540952364 ()


  • Nucleic acid amplification primer IVD
The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB Alert IC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays.
Elitechgroup Mdx LLC
M800734
In Commercial Distribution

  • 03661540952333 ()


  • Nucleic acid amplification primer IVD
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. QTY-100@480 reactions.
ELITECH GROUP INC.
800432-100
In Commercial Distribution

  • 03661540952302 ()
800432-100

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC2-C consists of reagents intended for use as an un-assayed 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. QTY-25@480 reactions.
ELITECH GROUP INC.
800432-25
In Commercial Distribution

  • 03661540952296 ()
800432-25

  • Exogenous DNA/RNA internal control IVD, kit
No Description
ELITECH GROUP INC.
800363-100
In Commercial Distribution

  • 03661540952265 ()
800363-100

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an un-assayed 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. QTY-25@480 reactions.
ELITECH GROUP INC.
800363-25
In Commercial Distribution

  • 03661540952258 ()
800363-25

  • Exogenous DNA/RNA internal control IVD, kit
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