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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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INFLIXIMAB LEVEL 3
UTAK LABORATORIES, INC.
INFLIX QC 3 UPHS
In Commercial Distribution

  • B800INFLIXQC3UPHS5 ()
  • B800INFLIXQC3UPHS0 ()

  • Total Volume: 1 Milliliter
INFLIX QC 3 UPHS

  • Multiple-type clinical chemistry analyte profile IVD, control
"MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV."
Elitechgroup Mdx LLC
800334
In Commercial Distribution

  • 03661540951299 ()
800334

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"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."
Elitechgroup Mdx LLC
800333
In Commercial Distribution

  • 03661540951282 ()
800333

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Legionella pneumophila Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the macrophage infectivity potentiator (mip) gene region of Legionella pneumophila. The mix consists of one probe at 1.44 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
M800685
In Commercial Distribution

  • 03661540951206 ()
M800685

  • Legionella pneumophila nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Legionella pneumophila Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Legionella pneumophila. The mix consists of a total of 9.00 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 89 bp nucleic acid sequence from the macrophage infectivity potentiator (mip) gene region of Legionella pneumophila.
Elitechgroup Mdx LLC
M800684
In Commercial Distribution

  • 03661540951190 ()
M800684

  • Legionella pneumophila nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® JC Virus Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP2 Tantigen region of JC Virus. 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
M800602
In Commercial Distribution

  • 03661540950360 ()
M800602

  • JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Trichomonas vaginalis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Trichomonas vaginalis. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 67 bp nucleic acid sequence from a repeated DNA fragment in Trichomonas vaginalis."
Elitechgroup Mdx LLC
M800583
In Commercial Distribution

  • 03661540950223 ()
M800583

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect a repeated DNA fragment in Trichomonas vaginalis. The mix consists of one probe at 0.56 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.
Elitechgroup Mdx LLC
M800582-am
In Commercial Distribution

  • 03661540950216 ()
M800582-am

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect a repeated DNA fragment in Trichomonas vaginalis. The mix consists of one probe at 0.56 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."
Elitechgroup Mdx LLC
M800582
In Commercial Distribution

  • 03661540950209 ()
M800582

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody inactivated form. An initial high-temperature incubation step denatures the antibodies to activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM MgCl2 are provided for additional flexibility in optimizing reaction conditions.
Elitechgroup Mdx LLC
M800331-am
In Commercial Distribution

  • 03661540950193 ()
M800331-am

  • Nucleic acid amplification mastermix kit IVD
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