Duns Number:080778937
Device Description: The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sa The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).
Catalog Number
20-006-018
Brand Name
Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge
Version/Model Number
20-006-018
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN120014,K122514,DEN120014,K122514
Product Code
NQX
Product Code Name
SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
Public Device Record Key
c237ef1b-3fec-468d-819d-ec807e3c597c
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
December 05, 2019
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 | 47 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |