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QuikRead go CRP
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 135171Ref 145217Ref 135175
by Aidian Oy
Identity
- Trade Name
- QuikRead go CRP EUDAMEDQuikRead go CRP Control Set EUDAMEDQuikRead go® CRP Control set FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, control FDA UDI
- Device Name
- QuikRead go CRP EUDAMEDQuikRead go CRP Control Set EUDAMEDQuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go CRP assay with the QuikRead go Instrument. FDA UDI
- Model / Reference
- 135171 EUDAMED145217 EUDAMEDFDA UDI135175 EUDAMED
- Description
- QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go CRP assay with the QuikRead go Instrument. FDA UDI
Identifiers
- Catalog Number
- 145217 FDA UDI
- Primary DI / UDI-DI
- 06438115000860 EUDAMED06438115000112 EUDAMEDFDA UDI06438115000921 EUDAMED
- Basic UDI-DI
- B-06438115000860 EUDAMEDB-06438115000112 EUDAMEDB-06438115000921 EUDAMED
- 510(k) Number
- K142993 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102160601 C-REACTIVE PROTEIN - RT & POC EUDAMEDW010302080501 HEMOSTASIS CONTROLS 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
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
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-06438115000860 | 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 (4)
- EUDAMED 57c4c4f9-db63-45ea-a59c-cb95a22bed59 61 fields · synced Jul 12, 2026
- EUDAMED 7f50c2a9-91cd-41f6-ae3c-653f19fe3ac5 61 fields · synced May 17, 2026
- EUDAMED b179119e-4108-4c62-9765-fe03a86c59e9 61 fields · synced May 19, 2026
- FDA UDI 45255bb0-aff9-4737-bfa3-49e79f304003 37 fields · synced May 30, 2026