Duns Number:962385787
Device Description: DBIL (Direct Bilirubin) 4 x 150 tests
Catalog Number
ST229
Brand Name
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 DBIL RGT KIT Product No. ST229
Version/Model Number
ST229
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
Yes
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
2750df6f-2169-478a-8c9a-0cf950e0dfd2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 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 | 144 |
2 | A medical device with a moderate to high risk that requires special controls. | 183 |
U | Unclassified | 7 |