Duns Number:276816717
Device Description: The VITEK® MS MOULD KIT provides the reagents and consumables needed to process samples by The VITEK® MS MOULD KIT provides the reagents and consumables needed to process samples by protein extraction and inactivation for mould identification from agar plates by the VITEK® MS System.
Catalog Number
-
Brand Name
VITEK® MS MOULD KIT
Version/Model Number
VITEK® MS MOULD KIT
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"
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For Single-Use
-
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
K162950
Product Code
PEX
Product Code Name
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Public Device Record Key
f9a4a023-4d79-469b-bac7-26af288f1466
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 21, 2017
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |