Elitechgroup Mdx LLC

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

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Device Description : "MGB Alert® HHV-6 Probe Mix is an analyte specific reagent that contains a chemi "MGB Alert® HHV-6 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acidsequences from HHV-6. The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluoresceinand 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

Product Code : MVU

Prescription Use : No

Device Count : 1

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

Product Code : MVU

Prescription Use : No

Device Count : 1

Device Description : The MGB Alert Internal Control Set IC1 consists of reagents intended for use as The MGB Alert Internal Control Set IC1 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 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended 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 Set IC2 consists of reagents intended for use as The MGB Alert Internal Control Set IC2 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 IC2 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended 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 Set IC2-B consists of reagents intended for use a The MGB Alert Internal Control Set IC2-B 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 IC2-B 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 : No

Product Code : OLD

Prescription Use : No

Device Count : 1

Device Description : The MGB Alert Internal Control Set IC2-C consists of reagents intended for use a The MGB Alert Internal Control Set IC2-C 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 IC2-C 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 : The MGB Alert Internal Control Set IC2-C consists of reagents intended for use a The MGB Alert Internal Control Set IC2-C 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 IC2-C 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 : The MGB Alert Internal Control Set IC1-V consists of reagents intended for use a The MGB Alert Internal Control Set IC1-V 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-V 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 : The MGB Alert Internal Control Set IC1-A consists of reagents intended for use a The MGB Alert Internal Control Set IC1-A 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-A 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 : The MGB Alert Internal Control Set IC2-H consists of reagents intended for use a The MGB Alert Internal Control Set IC2-H 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 IC2-H 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