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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® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the major capsid protein VP1 gene of the BK Virus.
Elitechgroup Mdx LLC
M800727
In Commercial Distribution

  • 03661540952357 ()


  • Nucleic acid amplification primer IVD
MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the major capsid protein VP1 gene of the BK Virus
Elitechgroup Mdx LLC
M800726
In Commercial Distribution

  • 03661540952340 ()


  • 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
MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800733
In Commercial Distribution

  • 03661540952326 ()


  • Nucleic acid amplification primer IVD
MGB Alert® BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800732
In Commercial Distribution

  • 03661540952319 ()


  • 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
MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. 25 vials; each 480 reactions.
ELITECH GROUP INC.
800333-25
In Commercial Distribution

  • 03661540952289 ()
800333-25

  • BK virus (BKV) 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. QTY 25 @ 480 reactions.
ELITECH GROUP INC.
800332-25
In Commercial Distribution

  • 03661540952272 ()
800332-25

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
ELITECH GROUP INC.
800363-100
In Commercial Distribution

  • 03661540952265 ()
800363-100

  • Exogenous DNA/RNA internal control IVD, kit
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