Elitechgroup Mdx LLC

Address:21720 23rd Dr SE, Suite 150,Bothell,WA,98021,US

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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

Product Code : MVU

Prescription Use : No

Device Count : 1

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

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : "MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonuc "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

Product Code : MVU

Prescription Use : No

Device Count : 1

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 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.

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Device Description : The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2 The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X mastermix containing a thermostable polymerase with exonuclease activity and provided in hot-start format.Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separatetubes.

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Device Description : "MGB Alert® Chlamydophila pneumoniae Primer Mix contains chemically synthesized "MGB Alert® Chlamydophila pneumoniae Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequencesfrom Chlamydophila pneumoniae . The mix consists of a total of 7.20 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 80 bpnucleic acid sequence from the Major Outer Membrane Protein gene region of Chlamydophila pneumoniae."

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that co MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the Major Outer Membrane protein gene region of Chlamydophila pneumoniae. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with fluorescein (FAM) 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

Product Code : MVU

Prescription Use : No

Device Count : 1

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

Product Code : PPM

Prescription Use : No

Device Count : 1

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

Product Code : PPM

Prescription Use : No

Device Count : 1

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

Product Code : PPM

Prescription Use : No

Device Count : 1