Identity
- Trade Name
- Coagulation Factor VIII Deficient Plasma FDA UDI
- Generic Name
- Coagulation factor VIII IVD, reagent FDA UDI
- Device Name
- For the determination of the activity of coagulation factor VIII in human plasma by coagulometric methods FDA UDI
- Model / Reference
- 10873880 FDA UDI
- Description
- For the determination of the activity of coagulation factor VIII in human plasma by coagulometric methods FDA UDI
Identifiers
- Catalog Number
- 10873880 FDA UDI
- Primary DI / UDI-DI
- 00630414640761 FDA UDI
- 510(k) Number
- K924396 FDA UDI
- FDA Product Code
- GJT FDA UDI
- GMDN Term
- Coagulation factor VIII 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: Coagulation factor VIII IVD, reagent
Coagulation Factor VIII Deficient Plasma by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Coagulation factor VIII IVD, reagent.
- George King Factor VIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor VIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- CRYOcheck Factor VIII Deficient Plasma with VWF — Precision Biologic · Class II
- George King Factor VIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- Factor VIII Deficient Substrate Plasma — Helena Laboratories, Corp. · Class II
- George King Factor FVIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor VIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor VIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
Cleared under the same submission
K924396 also covers:
- Coagulation Factor IX Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Coagulation Factor IX Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Coagulation Factor VIII Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Coagulation Factor XI Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Coagulation Factor XI Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Coagulation Factor XII Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Coagulation Factor XII Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 43ad139d-0bb4-4576-9763-27bab00d80ec 37 fields · synced May 30, 2026