Elitechgroup Mdx LLC

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

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Device Description : "MGB Alert® JC Virus Primer Mix contains chemically synthesized DNA oligonucleot "MGB Alert® JC Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from JC Virus. Themix consists of a total of 6.48 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 78 bp nucleic acid sequence from the VP2 Tantigen region of JC Virus"

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : "MGB Alert® JC Virus Probe is an analyte specific reagent that contains a chemic "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."

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : MGB Alert® Parvovirus B19 Primer Mix contains chemically synthesized DNA oligonu MGB Alert® Parvovirus B19 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences fromParvovirus B19. The mix consists of a total of 4.50 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 88 bp nucleic acidsequence from the VP1 Capsid Protein (VP1u) gene region of Parvovirus B19.

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : "MGB Alert® Parvovirus B19 Probe is an analyte specific reagent that contains a "MGB Alert® Parvovirus B19 Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP1Capsid Protein (VP1u) gene region of Parvovirus B19. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe islabeled 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

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : MGB Alert® Legionella pneumophila Primer Mix contains chemically synthesized DNA 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.

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : "MGB Alert® Legionella pneumophila Probe is an analyte specific reagent that con "MGB Alert® Legionella pneumophila Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detectthe macrophage infectivity potentiator (mip) gene region of Legionella pneumophila. The mix consists of one probe at 1.44 nmol per vial in a 1X TEbuffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelengthmaxima of 517 nm."

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : "MGB Alert® Pan Legionella Primer Mix contains chemically synthesized DNA oligon "MGB Alert® Pan Legionella Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences fromLegionella micadadei. The mix consists of a total of 9.00 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 105 bp nucleic acidsequence from the ssrA gene region of Legionella micdadei."

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : "MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a "MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrAgene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 andhas an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm"

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : The MGB Alert Internal Control Set IC1-L consists of reagents intended for use a The MGB Alert Internal Control Set IC1-L 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-L 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

Product Code : OLD

Prescription Use : No

Device Count : 1

Device Description : "MGB Alert® hMPV Primer Mix contains chemically synthesized DNA oligonucleotides "MGB Alert® hMPV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from hMPV (humanMetapneumovirus). The mix consists of a total of 8.4 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 186 nucleic acidsequence from the Polymerase (L) gene of hMPV."

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1