Duns Number:388240673
Device Description: Assayed accuracy and precision controls in the determination of free light chains (FLC) ty Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems.
Catalog Number
OPJE05
Brand Name
N FLC CONTROL SL1
Version/Model Number
10873661
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
K171742,K171742
Product Code
JJY
Product Code Name
Multi-analyte controls, all kinds (assayed)
Public Device Record Key
bb4d20a0-1f17-4b26-b60c-b5da4f282d18
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
October 08, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |