Duns Number:126544316
Device Description: A in vitro diagnostic test for the quantitative determination of C-reactive protein as an A in vitro diagnostic test for the quantitative determination of C-reactive protein as an aid in the detection and evaluation of infection, tissue injury, inflammation, and associated diseases.
Catalog Number
-
Brand Name
Fluoro-CheckTM CRP Test
Version/Model Number
TF3163
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
aeb4f9b0-35a7-4d26-a5c3-4fa01f75d157
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-