Duns Number:112942404
Device Description: Total Bilirubin Reagent Kit for use with EasyRA Analyzers
Catalog Number
10207-4
Brand Name
TBIL Reagent Kit
Version/Model Number
10207-4
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
K080810
Product Code
CIG
Product Code Name
Diazo Colorimetry, Bilirubin
Public Device Record Key
3849a07a-947b-461e-944f-496de239d53a
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 14, 2019
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 82 |