Duns Number:388240673
Device Description: Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in hu Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum
Catalog Number
OUAX31
Brand Name
RapiTex® CRP
Version/Model Number
10446419
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K903853
Product Code
DCN
Product Code Name
SYSTEM, TEST, C-REACTIVE PROTEIN
Public Device Record Key
6f067bc1-2372-4fe9-a010-6a1ee8f2c7a6
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 24, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |