Elitechgroup Mdx LLC

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

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Device Description : MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligo MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BKVirus.

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 DSQ contains the MGB Alert IC1 DNA Templa The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB AlertIC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acidextraction and amplification processes associated with real-time PCR assays.

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : OLD

Prescription Use : No

Device Count : 1

Device Description : MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligo MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BKVirus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the majorcapsid protein VP1 gene of the BK Virus

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligo MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BKVirus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the majorcapsid protein VP1 gene of the BK Virus.

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 DSQ contains the MGB Alert IC1 DNA Templa The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB AlertIC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acidextraction and amplification processes associated with real-time PCR assays.

Device Class : 1

Duns Number: 117458512

Premarket Exempt : Yes

Product Code : OLD

Prescription Use : No

Device Count : 1

Device Description : The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended f The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC1 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not 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 : The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended f The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not 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 : The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended f The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not 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 : The MGB Alert Internal Control MS2 DNA Template consists of a DNA plasmid intend The MGB Alert Internal Control MS2 DNA Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not 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 : The MGB Alert Internal Control MS2 RNA Template consists of an RNA bacteriophage The MGB Alert Internal Control MS2 RNA Template consists of an RNA bacteriophage intended for use as an internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not 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