Duns Number:117458512
Device Description: "The MGB Alert Platinum Master Mix is intended for use in the development of laboratory as "The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays whichtarget DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates nodiagnostic information or data."
Catalog Number
M800694
Brand Name
MGB Alert Platinum Master Mix with water-480rxn
Version/Model Number
M800694
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
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
98fdef8c-231b-4a15-9516-1bd074bd31fc
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 |