Duns Number:086785110
Device Description: The VITEK® 2 NH Identification Card is intended for use with the VITEK 2 Systems for ID of The VITEK® 2 NH Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important Neisseria, Haemophilus and other fastidious GN bacteria
Catalog Number
-
Brand Name
VITEK® 2 NH
Version/Model Number
VITEK® 2 NH
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
-
Product Code
JST
Product Code Name
KIT, FASTIDIOUS ORGANISMS
Public Device Record Key
151f682a-1f73-4d75-8166-385fa23c2e58
Public Version Date
May 10, 2022
Public Version Number
2
DI Record Publish Date
June 02, 2020
Package DI Number
03573026144357
Quantity per Package
20
Contains DI Package
03573026529710
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |