Identity
- Trade Name
- vW Abnormal Control Plasma EUDAMEDFDA UDI
- Generic Name
- von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, control FDA UDI
- Device Name
- vW Abnormal Control Plasma EUDAMED
- Model / Reference
- 101270 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 101270 FDA UDI
- Primary DI / UDI-DI
- *+G0561012701/ $$0100058XXXXXX* EUDAMEDG0561012701 FDA UDI
- Basic UDI-DI
- ++G0561012703E EUDAMED
- FDA Product Code
- GGP FDA UDI
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, control FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, control
vW Abnormal Control Plasma by Bio/Data Corp. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, control.
- Ristocetin Cofactor Abnormal Control Plasma — Helena Laboratories, Corp. · Class II
- vW Normal Reference Plasma — Bio/Data Corp. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bio/Data Corp.
Sources (2)
- FDA UDI 92cb758d-4dae-413f-90c6-e8792cd294c2 33 fields · synced Jul 24, 2026
- EUDAMED b1e01000-be3d-4b3d-9dc3-68e1f41349eb 61 fields · synced Jul 24, 2026