Duns Number:388240673
Device Description: Calibration of RF, ASL and CRP assays on BN Systems
Catalog Number
OQKZ15
Brand Name
N Rheumatology Standard SL
Version/Model Number
10873683
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
K964527,K964527
Product Code
JIX
Product Code Name
Calibrator, multi-analyte mixture
Public Device Record Key
42b3944b-cd73-4079-9540-f276a5c816c2
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
February 14, 2020
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |