Address:21720 23rd Dr SE, Suite 150,Bothell,WA,98021,US
Device Description : The MGB Alert Platinum Master Mix is intended for use in the development of labo The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : "The MGB Alert Platinum Master Mix is intended for use in the development of lab "The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays whichtarget DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates nodiagnostic information or data."
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : The MGB Alert Internal Control Set IC1-C consists of reagents intended for use a 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
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : "MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific rea "MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designedto detect nucleic acid sequences from the insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis.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 anexcitation 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 HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) base The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection.
Device Class : 2
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : "MGB Alert® B. pertussis / B. parapertussis Primer Mix contains chemically synth "MGB Alert® B. pertussis / B. parapertussis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acidsequences from Bordetella pertussis and Bordetella parapertussis. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution.The primers amplify insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis."
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : "MGB Alert® HHV-6 2.0 Primer Mix contains chemically synthesized DNA oligonucleo "MGB Alert® HHV-6 2.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Humanherpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of a total of 2.8 nmol of primers per vial in a 1X TE buffer solution.The primers amplify a region of the U67 gene."
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : "MGB Alert® HHV-6 2.0 Probe Mix is an analyte specific reagent that contains a c "MGB Alert® HHV-6 2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from the U67 gene of Human herpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of one probe at 0.56nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and anemission wavelength maxima of 516 nm. "
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : SARS-CoV-2 ELITe MGB® Assay is a real-time RT-PCR test intended for the presumpt SARS-CoV-2 ELITe MGB® Assay is a real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swabs from individuals with signs and symptoms of infection who are suspected of COVID-19.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA olig MGB Alert® BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No