Duns Number:064608573
Device Description: Calcitonin (CALCT) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1.0mL
Catalog Number
10995094
Brand Name
ADVIA Centaur Calcitonin MCM
Version/Model Number
10995094
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJX
Product Code Name
Single (specified) analyte controls (assayed and unassayed)
Public Device Record Key
e69a8a3d-b1d3-4cde-baf2-22d8f31f7adb
Public Version Date
November 18, 2021
Public Version Number
4
DI Record Publish Date
July 05, 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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |