Duns Number:171857493
Device Description: BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Pro BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Protein (CRP) in human serum.
Catalog Number
BC-1119
Brand Name
BioCheck High Sensitive CRP EIA Test Kit
Version/Model Number
BC-1119
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
K003851
Product Code
DCK
Product Code Name
C-Reactive Protein, Antigen, Antiserum, And Control
Public Device Record Key
019ba6eb-6c92-49c3-a4fd-060a7ef8cd4f
Public Version Date
October 16, 2019
Public Version Number
1
DI Record Publish Date
October 08, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |