Duns Number:117458512
Device Description: SARS-CoV-2 ELITe MGB® Assay is a real-time RT-PCR test intended for the presumptive qualit SARS-CoV-2 ELITe MGB® Assay is a real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swabs from individuals with signs and symptoms of infection who are suspected of COVID-19.
Catalog Number
M800703
Brand Name
SARS-CoV-2 ELITe MGB Assay
Version/Model Number
M800703
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
c257312e-b92e-4617-a9c3-e7d8553641f8
Public Version Date
October 15, 2020
Public Version Number
2
DI Record Publish Date
September 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |