Duns Number:830140377
Device Description: The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in v The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli.
Catalog Number
-
Brand Name
iC-GN Assay
Version/Model Number
iCC-AAQA00000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K190341
Product Code
PEN
Product Code Name
Gram-Negative Bacteria And Associated Resistance Markers
Public Device Record Key
ebc00bb2-ee17-4320-856c-ea0579735099
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
July 15, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |