Duns Number:227530649
Device Description: Intended for in vitro diagnostic (IVD) use as a quality control material for determination Intended for in vitro diagnostic (IVD) use as a quality control material for determination of Total Bilirubin and Direct Bilirubin on chemistry analysers. For use in a clinical laboratory setting by trained personnel.
Catalog Number
BR10442
Brand Name
LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1)
Version/Model Number
BR10442
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
Yes
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
-
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
f4428427-d98e-4acc-861b-50000bcf5c70
Public Version Date
September 28, 2022
Public Version Number
1
DI Record Publish Date
September 20, 2022
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |