Identity
- Trade Name
- CRYOcheck Factor VIII Deficient Plasma with VWF FDA UDI
- Generic Name
- Coagulation factor VIII IVD, reagent FDA UDI
- Device Name
- CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% sodium citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying Factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use. CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and which contains normal levels of von Willebrand Factor (VWF), buffered with HEPES. Factor VIII has been assayed at less than 1% of normal antigen and activity levels while VWF antigen and activity levels are >50%. Device is provided frozen as 25 vials of 1.0 mL FDA UDI
- Model / Reference
- FDP08VWF FDA UDI
- Description
- CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% sodium citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying Factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use. CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and which contains normal levels of von Willebrand Factor (VWF), buffered with HEPES. Factor VIII has been assayed at less than 1% of normal antigen and activity levels while VWF antigen and activity levels are >50%. Device is provided frozen as 25 vials of 1.0 mL FDA UDI
Identifiers
- Catalog Number
- FDP08VWF-15 FDA UDI
- Primary DI / UDI-DI
- 00843876000589 FDA UDI
- 510(k) Number
- K222831 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
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: Coagulation factor VIII IVD, reagent
CRYOcheck Factor VIII Deficient Plasma with VWF by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Coagulation Factor VIII Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Coagulation Factor VIII Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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
Cleared under the same submission
K222831 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
- Precision Biologic
Sources (1)
- FDA UDI 3e461d29-ccc6-40d9-ae5d-9b137d9d1f30 36 fields · synced Jun 1, 2026