Duns Number:215865786
Device Description: VITROS Immunodiagnostic Products Vitamin B12 Calibrators
Catalog Number
1540525
Brand Name
VITROS
Version/Model Number
1540525
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
K013899
Product Code
CDD
Product Code Name
RADIOASSAY, VITAMIN B12
Public Device Record Key
e22b1aac-c680-4b66-9f93-b0f32d03f6f8
Public Version Date
August 05, 2022
Public Version Number
5
DI Record Publish Date
August 26, 2016
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 | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 17 |