Identity
- Trade Name
- vW Normal Control Plasma FDA UDI
- Generic Name
- von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent FDA UDI
- Model / Reference
- 106426 FDA UDI
Identifiers
- Catalog Number
- 106426 FDA UDI
- Primary DI / UDI-DI
- G0561064261 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
vW Normal 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, reagent.
- BC von Willebrand Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Ristocetin Cofactor Assay Kit — Helena Laboratories, Corp. · Class II
- Lyophilized Platelets — Helena Laboratories, Corp. · Class II
- Lyophilized Platelets — Helena Laboratories, Corp. · Class II
- BC von Willebrand Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Helena Ristocetin - 10 mg/mL — Helena Laboratories, Corp. · Class II
- Lyophilized Platelets — Bio/Data Corp. · Class II
- vW Factor Assay (Ristocetin Cofactor) — Bio/Data Corp. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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 676032d9-c375-4541-8f2f-94951e9ddcc9 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026