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QuikRead go CRP Verification Set
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref 145216
by Aidian Oy
Identity
- Trade Name
- QuikRead go CRP Verification Set EUDAMEDQuikRead go® CRP Verification set FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, control FDA UDI
- Device Name
- QuikRead go CRP Verification Set EUDAMEDQuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. It is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. FDA UDI
- Model / Reference
- 145216 EUDAMEDFDA UDI
- Description
- QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. It is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. FDA UDI
Identifiers
- Catalog Number
- 145216 FDA UDI
- Primary DI / UDI-DI
- 06438115000105 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438115000105 EUDAMED
- 510(k) Number
- K142993 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102160601 C-REACTIVE PROTEIN - RT & POC EUDAMED
- GMDN Term
- C-reactive protein (CRP) IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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 Verification Set by Aidian Oy — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142993 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06438115000105 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (3)
- EUDAMED 84e71aef-5415-4a53-9708-253d0ff932f9 61 fields · synced Jul 17, 2026
- FDA UDI e6f8cdc1-cff7-4d3b-b176-32af630bece4 37 fields · synced May 30, 2026
- FDA 510(k) K142993 1 fields · synced May 18, 2026