Duns Number:125006353
Device Description: For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma.
Catalog Number
BR2
Brand Name
Advanced Instruments BR2 Bilirubin Stat-Analyzer
Version/Model Number
BR2
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
-
Product Code
CIG
Product Code Name
Diazo Colorimetry, Bilirubin
Public Device Record Key
cc267749-dfaa-49b3-8db7-90fb37150049
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
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 | 50 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |