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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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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
The DSQ Alert MS2-ICB-1 Internal Control Set 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 MS2-ICB-1 Internal Control Set can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. This set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800707
In Commercial Distribution

  • 03661540952098 ()
M800707

  • Exogenous DNA/RNA internal control IVD, kit
The MGB Alert Internal Control Set IC1-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 IC1-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
800361
In Commercial Distribution

  • 03661540951862 ()
800361

  • Exogenous DNA/RNA internal control IVD, kit
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
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