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QuikRead go CRP
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 145215
by Aidian Oy
Identity
- Trade Name
- QuikRead go CRP EUDAMEDQuikRead go® CRP FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- QuikRead go CRP EUDAMEDQuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP). The test is carried out by means of the QuikRead go® instrument. FDA UDI
- Model / Reference
- 145215 EUDAMEDFDA UDI
- Description
- QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP). The test is carried out by means of the QuikRead go® instrument. FDA UDI
Identifiers
- Catalog Number
- 145215 FDA UDI
- Primary DI / UDI-DI
- 06438115000099 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438115000099 EUDAMED
- 510(k) Number
- K142993 FDA UDI
- FDA Product Code
- DCK FDA UDI
- EMDN Code
- W0102160601 C-REACTIVE PROTEIN - RT & POC EUDAMED
- GMDN Term
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5270 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
QuikRead go CRP by Aidian Oy — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438115000099 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (2)
- EUDAMED 04177de2-0383-482c-adb8-18b2c4f80d80 61 fields · synced Jul 10, 2026
- FDA UDI ab156e02-ee23-4b00-bf7d-3a86a4268248 37 fields · synced May 30, 2026