Identity
- Trade Name
- CRYOcheck™ Factor VIII Deficient Plasma FDA UDI
- Generic Name
- Multiple coagulation factor IVD, reagent FDA UDI
- Model / Reference
- FDP08-40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843876000299 FDA UDI
- 510(k) Number
- K971225 FDA UDI
- FDA Product Code
- GJT FDA UDI
- GMDN Term
- Multiple coagulation factor 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: Multiple coagulation factor IVD, reagentCoagulation factor VIII IVD, reagent
CRYOcheck™ Factor VIII Deficient Plasma 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
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 5e274124-b8fe-41ed-bd2d-a8907754251a 33 fields · synced Jun 6, 2026