Identity
- Trade Name
- Factor IX Deficient Substrate Plasma FDA UDI
- Generic Name
- Coagulation factor IX IVD, reagent FDA UDI
- Model / Reference
- 5194 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52551940 FDA UDI
- 510(k) Number
- K792475 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Coagulation factor IX 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
Yes
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 IX IVD, reagent
Factor IX Deficient Substrate Plasma by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor IX IVD, reagent.
- George King Factor IX Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor IX Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Congential Factor Deficiency Convenience Kit — GEORGE KING BIO-MEDICAL, INC. · Class II
- CRYOcheck™ Factor IX Deficient Plasma — Precision Biologic · Class II
- George King Factor IX Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor IX Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- George King Factor IX Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- CRYOcheck™ Factor IX Deficient Plasma — Precision Biologic · Class II
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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 10632ce4-19fa-47d7-95ec-0b0e1e106b80 34 fields · synced Jun 9, 2026