Duns Number:117458512
Device Description: "MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific reagent that "MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designedto detect nucleic acid sequences from the insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis.The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6-carboxyfluorescein, which has anexcitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Catalog Number
800438
Brand Name
MGB Alert® Bordetella P/PP Probe Mix ASR - 48 Reactions
Version/Model Number
800438
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
ac31890e-d291-4347-bcb0-39b21df3a354
Public Version Date
October 15, 2020
Public Version Number
2
DI Record Publish Date
September 08, 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 |