MGB Alert® EBV Probe Mix ASR - 480 Reactions - "MGB Alert® EBV Probe Mix is an analyte specific - Elitechgroup Mdx LLC

Duns Number:117458512

Device Description: "MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemically synthe "MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acidsequences from EBV (Epstein-Barr Virus). The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. "

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

800335

Brand Name

MGB Alert® EBV Probe Mix ASR - 480 Reactions

Version/Model Number

800335

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MVU

Product Code Name

Reagents, Specific, Analyte

Device Record Status

Public Device Record Key

ca2e27b1-7ea7-4e76-becb-371e32b74080

Public Version Date

October 15, 2020

Public Version Number

2

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELITECHGROUP MDX LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 106
2 A medical device with a moderate to high risk that requires special controls. 3