Duns Number:064608573
Device Description: ß2-Microglobulin (B2M) Calibrator Atellica CH - CAL 3 x 1.0mL
Catalog Number
11099442
Brand Name
Atellica CH B2M Calibrator
Version/Model Number
11099442
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
K110874,K110874
Product Code
JIT
Product Code Name
Calibrator, secondary
Public Device Record Key
fdeee13d-f448-452a-8dbc-246ba1bb8555
Public Version Date
October 10, 2022
Public Version Number
6
DI Record Publish Date
February 06, 2018
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 |