Address:21720 23rd Dr SE, Suite 150,Bothell,WA,98021,US
Device Description : MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct dete MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Device Class : 2
Duns Number: 117458512
Premarket Exempt : No
Prescription Use : Yes
Device Description : The United States (US) Food and Drug Administration (FDA) has issued an Emergenc The United States (US) Food and Drug Administration (FDA) has issued an Emergency UseAuthorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitroqualitative detection of Zika virus with specified instruments. This assay tests for Zika virusRNA in human serum and EDTA plasma.
Device Class :
Duns Number: 117458512
Premarket Exempt : No
Prescription Use : Yes
Device Description : HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and other materials intended to be used for the qualitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT). This is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections.
Device Class : 2
Duns Number: 117458512
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MGB Alert Internal Control Set IC2-BH consists of reagents intended for use The MGB Alert Internal Control Set IC2-BH consists of reagents intended for use as an unassayed internal extraction andamplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-BH can be usedto detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. Theset 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® Pneumocystis Probe Mix is an analyte specific reagent that contains a MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detectnucleic 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 probeis labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® Pneumocystis Primer Mix contains chemically synthesized DNA oligonucl MGB Alert® Pneumocystis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences fromPneumocystis 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 acidsequence from the multi-copy mitochondrial large subunit rRNA (mtLSU) gene of Pneumocystis jirovecii.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucl MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1and 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 54nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a ch MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid 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. Theprobe dye 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 : MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucl MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1and 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 54nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Device Class : 1
Duns Number: 117458512
Premarket Exempt : Yes
Prescription Use : No
Device Description : MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a ch MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid 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. Theprobe dye 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