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CHRONO-LOG Ristocetin CoFactor Assay
EUDAMEDFDA UDIClass A (EU MDR)
Ref 299 Ristocetin CoFactor Assay
Identity
- Trade Name
- CHRONO-LOG Ristocetin CoFactor Assay EUDAMEDChrono-log FDA UDI
- Generic Name
- Platelet aggregation study IVD, reagent FDA UDI
- Device Name
- Reagent EUDAMEDRistocetin Cofactor Assay Kit FDA UDI
- Model / Reference
- 299 Ristocetin CoFactor Assay EUDAMED299 FDA UDI
- Description
- Ristocetin Cofactor Assay Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811476010161 EUDAMEDFDA UDI
- Basic UDI-DI
- 081147601Reagents5Z6 EUDAMED
- 510(k) Number
- K945414 FDA UDI
- FDA Product Code
- GGP FDA UDI
- EMDN Code
- W0103010605,W01030199 EUDAMED
- GMDN Term
- Platelet aggregation study IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
New Device
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
Yes
FDA UDI
CHRONO-LOG Ristocetin CoFactor Assay by Chrono-Log Corp — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081147601Reagents5Z6 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Chrono-log Corp
- EUDAMED SRN
- US-MF-000018631
- Authorised Representative
- BioTop Medical NL-AR-000012565
Sources (2)
- EUDAMED 0e2b8cda-5355-46a5-b0a4-33e42bdd0ad2 61 fields · synced Jul 23, 2026
- FDA UDI 12948a9c-c338-48ec-9dbf-9de525c46674 36 fields · synced May 30, 2026