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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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LEAD 70 UG/DL
UTAK LABORATORIES, INC.
LEAD 70 WB ACL
In Commercial Distribution

  • B800LEAD70WBACL5 ()
  • B800LEAD70WBACL0 ()

  • Total Volume: 3 Milliliter
LEAD 70 WB ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 5
UTAK LABORATORIES, INC.
LEAD 5 WB F LGC
In Commercial Distribution

  • B800LEAD5WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 5 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 4
UTAK LABORATORIES, INC.
LEAD 3 WB F UCI
In Commercial Distribution

  • B800LEAD4WBFUCI5 ()
  • B800LEAD4WBFUCI0 ()

  • Total Volume: 3 Milliliter
LEAD 4 WB F UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 4 V4
UTAK LABORATORIES, INC.
EAD 4 V4 WB F CH
In Commercial Distribution

  • B800LEAD4V4WBFCH5 ()
  • B800LEAD4V4WBFCH0 ()

  • Total Volume: 0.5 Milliliter
EAD 4 V4 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
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
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-am
In Commercial Distribution

  • 03661540950186 ()
800495-am

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

  • 03661540950179 ()
800498-am

  • 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-am
In Commercial Distribution

  • 03661540950162 ()
800497-am

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
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-am
In Commercial Distribution

  • 03661540950155 ()
800427-am

  • Exogenous DNA/RNA internal control IVD, kit
MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of one probe at 0.5 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
800424-am
In Commercial Distribution

  • 03661540950148 ()
800424-am

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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
800414-am
In Commercial Distribution

  • 03661540950131 ()
800414-am

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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-am
In Commercial Distribution

  • 03661540950124 ()
800430-am

  • 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.
Elitechgroup Mdx LLC
800421-am
In Commercial Distribution

  • 03661540950117 ()
800421-am

  • 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.
Elitechgroup Mdx LLC
800411-am
In Commercial Distribution

  • 03661540950100 ()
800411-am

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye 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
M800588-am
In Commercial Distribution

  • 03661540950094 ()
M800588-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Elitechgroup Mdx LLC
M800587-am
In Commercial Distribution

  • 03661540950087 ()
M800587-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye 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
M800586-am
In Commercial Distribution

  • 03661540950070 ()
M800586-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Elitechgroup Mdx LLC
M800585-am
In Commercial Distribution

  • 03661540950063 ()
M800585-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® Pneumocystis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Pneumocystis jirovecii. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 156 bp nucleic acid sequence from the multi-copy mitochondrial large subunit rRNA (mtLSU) gene of Pneumocystis jirovecii.
Elitechgroup Mdx LLC
M800573
In Commercial Distribution

  • 03661540950056 ()
M800573

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe 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
M800572
In Commercial Distribution

  • 03661540950049 ()
M800572

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert Internal Control Set IC2-BH 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-BH 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
M800574
In Commercial Distribution

  • 03661540950032 ()
M800574

  • Exogenous DNA/RNA internal control IVD, kit
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