Duns Number:008171162
Device Description: Strip Description: For the in vitro quantitative determination of total bilirubin concent Strip Description: For the in vitro quantitative determination of total bilirubin concentration in human plasma from whole blood samples.
Catalog Number
-
Brand Name
SPOTCHEM™ II Total Bilirubin
Version/Model Number
77106
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051432,K051432
Product Code
CIX
Product Code Name
BROMCRESOL GREEN DYE-BINDING, ALBUMIN
Public Device Record Key
53f39212-ccd3-45f7-933e-1a61f502db7b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |