Identity
- Trade Name
- HemosIL Chromogenic Factor IX FDA UDI
- Generic Name
- Coagulation factor IX IVD, kit, chromogenic FDA UDI
- Device Name
- HemosIL Chromogenic Factor IX FDA UDI
- Model / Reference
- 0020012900 FDA UDI
- Description
- HemosIL Chromogenic Factor IX FDA UDI
Identifiers
- Catalog Number
- 0020012900 FDA UDI
- Primary DI / UDI-DI
- 00195226001129 FDA UDI
- 510(k) Number
- K230852 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Coagulation factor IX 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 IX IVD, kit, chromogenic
HemosIL Chromogenic Factor IX by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor IX IVD, kit, chromogenic.
- CRYOcheck Chromogenic Factor IX — Precision Biologic · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (2)
- FDA UDI 0628a009-da5f-42e2-8ed6-381e12a0a60a 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026