Duns Number:125006353
Device Description: For In Vitro Diagnostic Use. Advanced Instruments Total and Direct Bilirubin Test Kit has For In Vitro Diagnostic Use. Advanced Instruments Total and Direct Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, one 25mL bottle of Sulfanilic Acid Solution, one 25mL bottle of 0.2N Hydrochloric Acid, one 50mg Sodium Nitrite Tablet and 100 Cuvettes.
Catalog Number
B2A102
Brand Name
Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes
Version/Model Number
B2A102
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
CIG
Product Code Name
Diazo Colorimetry, Bilirubin
Public Device Record Key
7f114b5a-0380-4aea-8e32-508e349cd6c2
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 |