Identity
- Trade Name
- CRYOcheck Factor VIII Chromogenic FDA UDI
- Generic Name
- Coagulation factor VIII IVD, kit, chromogenic FDA UDI
- Device Name
- CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. 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 FDA UDI
- Model / Reference
- CCCF08 FDA UDI
- Description
- CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. 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 FDA UDI
Identifiers
- Catalog Number
- CCCF08 FDA UDI
- Primary DI / UDI-DI
- 00843876000558 FDA UDI
- 510(k) Number
- K193204 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Coagulation factor VIII IVD, kit, chromogenic 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
Yes
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, kit, chromogenic
CRYOcheck Factor VIII Chromogenic by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 7376ced9-c0fb-41af-a44d-066b49e55ef8 35 fields · synced May 30, 2026