Duns Number:045623154
Device Description: Total Bilirubin Reagent, for the quantitative determination of total bilirubin in serum on Total Bilirubin Reagent, for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 1 x 2L, 1 x 500ml
Catalog Number
HB979-2500
Brand Name
Pointe Scientific, Inc. Bilirubin, Total
Version/Model Number
HB979-2500
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
8bb49c34-66cb-4e5b-be85-cef57697f3d2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |