Duns Number:070371210
Device Description: For the quantitative determination of total bilirubin in serum using the Mindray BS480 ana For the quantitative determination of total bilirubin in serum using the Mindray BS480 analyzer. For in vitro diagnostic use only.5 x 58ml, 5 x 15ml.
Catalog Number
TIB480
Brand Name
MedTest DX Total Bilirubin for the BS480
Version/Model Number
TIB480
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
K832870
Product Code
CIG
Product Code Name
Diazo Colorimetry, Bilirubin
Public Device Record Key
9a265200-debe-4ec7-aa17-c06f1a536c84
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |