Duns Number:623873044
Device Description: VITROS XT Chemistry Products UREA-CREA Slides
Catalog Number
6844294
Brand Name
VITROS
Version/Model Number
6844294
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
-
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
K190326
Product Code
CDN
Product Code Name
UREASE, PHOTOMETRIC, UREA NITROGEN
Public Device Record Key
f83b3365-c891-490f-b47f-aa3a78cd1cfc
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
November 13, 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 | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| U | Unclassified | 1 |