Identity
- Trade Name
- BC von Willebrand Reagent FDA UDI
- Generic Name
- von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent FDA UDI
- Device Name
- Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination FDA UDI
- Model / Reference
- 10714565 FDA UDI
- Description
- Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination FDA UDI
Identifiers
- Catalog Number
- OUBD39 FDA UDI
- Primary DI / UDI-DI
- 00842768038211 FDA UDI
- 510(k) Number
- K972116 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
BC von Willebrand Reagent by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent.
- Lyophilized Platelets — Bio/Data Corp. · Class II
- vW Factor Assay (Ristocetin Cofactor) — Bio/Data Corp. · Class II
- vW Select Kit (Ristocetin Cofactor) — Bio/Data Corp. · Class II
- Lyophilized Platelets — Bio/Data Corp. · Class II
- Ristocetin Cofactor Assay Kit — Helena Laboratories, Corp. · Class II
- LTA Check CD — Bio/Data Corp. · Class I
- Lyophilized Platelets — Helena Laboratories, Corp. · Class II
- LTA Check Test Kit — Bio/Data Corp. · Class I
Cleared under the same submission
K972116 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 97bc67ac-01c5-4f4d-9138-070c06617709 37 fields · synced Jun 8, 2026