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Device Description : MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleoti 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.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a che MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid 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.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : The MGB Alert Internal Control Set IC2-B consists of reagents intended for use a The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-B can be used to detectsystemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set isnot intended to monitor other real-time PCR processes.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides d MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-BarrVirus). 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 thep140 region of the BNRF1 gene of EBV.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemical 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.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : The MGB Alert Internal Control Set IC1 consists of reagents intended for use as The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended to monitor other real-time PCR processes.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleo 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 knownAdenovirus types.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains che MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleicacid 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 TEbuffer solution. The probes are labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelengthmaxima of 516 nm.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : The MGB Alert Internal Control Set IC1-A consists of reagents intended for use a The MGB Alert Internal Control Set IC1-A consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-A can be used to detectsystemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set isnot intended to monitor other real-time PCR processes.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : The MGB Alert PCR Master Mix package includes ready to use 2x master mix contain The MGB Alert PCR Master Mix package includes ready to use 2x master mix containinga non-Taq thermostable enzyme lacking exonuclease activity and provided in antibodyinactivated form. An initial high-temperature incubation step denatures the antibodies toactivate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) anddUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mMMgCl2 are provided for additional flexibility in optimizing reaction conditions.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No