Identity
- Trade Name
- CHRONO-PAR® Ristocetin EUDAMEDCHRONO-PAR FDA UDI
- Generic Name
- Platelet aggregation study IVD, reagent FDA UDI
- Device Name
- Reagents EUDAMEDRistocetin FDA UDI
- Model / Reference
- 396 Ristocetin EUDAMED396 FDA UDI
- Description
- Ristocetin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811476010086 EUDAMEDFDA UDI
- Basic UDI-DI
- 081147601Reagents53 EUDAMED
- 510(k) Number
- K922800 FDA UDI
- FDA Product Code
- GHR FDA UDI
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Platelet aggregation study IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5700 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
No
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-PAR® Ristocetin 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 | 081147601Reagents53 | 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 83887741-9dd1-44a5-b34e-8649be70188d 61 fields · synced Jun 18, 2026
- FDA UDI 8aa1f258-a285-4c22-8a55-90812db474c8 36 fields · synced May 30, 2026