Duns Number:045623154
Device Description: Pointe Total Bilirubin Reagent packaged for use on the Mindray BA800. 5 x 63ml R1, 5 x 16 Pointe Total Bilirubin Reagent packaged for use on the Mindray BA800. 5 x 63ml R1, 5 x 16ml R2. For the quantitative determination of total bilirubin in serum. For in vitro diagnostic use only.
Catalog Number
16-HB979-395
Brand Name
Pointe Total Bilirubin Reagent
Version/Model Number
16-HB979-395
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
K040391
Product Code
CIG
Product Code Name
Diazo Colorimetry, Bilirubin
Public Device Record Key
5ebec481-e079-400a-aa8b-dfd09221ca9a
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 30, 2021
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |