Duns Number:193856866
Device Description: 10/17/2022
Catalog Number
GEN-TBILI R2
Brand Name
GENCHEM™ Total Bilirubin Reagent
Version/Model Number
GEN-TBILI R2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 19, 2020
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
9e3b9d75-7e4a-432b-ac05-9d5615b7b637
Public Version Date
October 21, 2022
Public Version Number
4
DI Record Publish Date
September 19, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 31 |