Duns Number:080778937
Device Description: The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sa The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
Catalog Number
20-006-021
Brand Name
Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge
Version/Model Number
20-006-021
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
K132843,K132843
Product Code
PEN
Product Code Name
Gram-Negative bacteria and associated resistance markers
Public Device Record Key
3f1ce5a9-513d-4d35-a166-6d85ca36dcfb
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 |