Duns Number:125006353
Device Description: For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been devel For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer. Contains one-hundred 4.5mL cuvettes.
Catalog Number
B2A800
Brand Name
Advanced Instruments BR2 Disposable Cuvettes
Version/Model Number
B2A800
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
58b5f021-9928-4a2d-9f29-8267cec92272
Public Version Date
November 19, 2020
Public Version Number
3
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 |