Duns Number:010717890
Device Description: The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin ass The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 2x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added.
Catalog Number
1330-01
Brand Name
Pediatric Bilirubin Control Level 1&2 Set 2x3mL
Version/Model Number
1330-01
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
K860942
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
90c1563a-5fbf-413b-8467-e6562021dd02
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 26, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |