NOFACT IX Plasma, Coagulation Factor Deficient
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- NoFact IX EUDAMEDFDA UDI
- Generic Name
- Coagulation factor IX IVD, kit, clotting FDA UDI
- Device Name
- NoFact IX EUDAMEDFactor IX immunodepleted 10 x 1 ml FDA UDI
- Model / Reference
- 69-201 EUDAMEDFDA UDI
- Description
- Factor IX immunodepleted 10 x 1 ml FDA UDI
Identifiers
- Catalog Number
- 69-201 FDA UDI
- Primary DI / UDI-DI
- 10859394006160 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10859394006160 EUDAMED
- 510(k) Number
- FDA Product Code
- GJT FDA 510(k)FDA UDI
- EMDN Code
- W0103020208 COAGULATION FACTOR IX EUDAMED
- GMDN Term
- Coagulation factor IX IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 864.7290 FDA 510(k)
- Regulation Number
- 864.7290 FDA 510(k)FDA UDI
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The NOFACT IX Plasma, Coagulation Factor Deficient is an immunodepleted plasma designed for coagulation factor assays. It is classified as a plasma product deficient in coagulation factors, specifically Factor IX, used to measure residual clotting activity in patient samples through dilution-based assays. This device aids in diagnosing and monitoring hemophilia by quantifying Factor IX levels in plasma samples.
NOFACT IX is supplied as a sterile, single-use reagent intended for in vitro diagnostic use in hematology laboratories. It is regulated under FDA 510(k) clearance (K102908) and classified as a Class II device under the In Vitro Diagnostic Device Directive (IVDD). The product is distributed in premeasured aliquots and must be stored refrigerated at 2–8°C. Compliance with regulatory standards ensures its suitability for clinical coagulation testing.
Frequently asked questions
What is the primary clinical use of the NOFACT IX Plasma, Coagulation Factor Deficient?
The NOFACT IX Plasma is specifically designed for coagulation factor assays to measure residual Factor IX activity in patient plasma samples. It helps diagnose and monitor hemophilia by quantifying Factor IX levels through dilution-based assays in hematology laboratories.
Is the NOFACT IX Plasma single-use or reusable, and how should it be stored?
The NOFACT IX Plasma is intended for single-use only. It must be stored refrigerated between 2–8°C to maintain its stability and ensure proper performance for in vitro diagnostic coagulation testing.
What regulatory pathways does the NOFACT IX Plasma follow, and what classification does it hold?
The NOFACT IX Plasma is cleared by the FDA under a 510(k) pathway (K102908) and classified as a Class II device. It also complies with the In Vitro Diagnostic Device Directive (IVDD), ensuring its suitability for clinical use in coagulation testing.
How is the NOFACT IX Plasma supplied, and what form does it take?
The NOFACT IX Plasma is supplied in premeasured aliquots, which simplifies handling and dosing for laboratory use. Each aliquot is sterile and intended for a single diagnostic assay.
What special handling or storage conditions are required for the NOFACT IX Plasma?
The NOFACT IX Plasma must be stored refrigerated at 2–8°C to preserve its sterility and functionality. It is not intended for reuse, so each aliquot should be used once and then discarded.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Nofact Ix 510 (k) FDA Premarket Notification K102908 R2 DIAGNOSTICS, INC., NoFact Immunodepleted Plasmas - r² Diagnostics, 510 (k) K102908 — NOFACT IX — RegDataLab
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K102908 | Class II | Active |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (3)
- FDA 510(k) K102908 24 fields · synced Sep 18, 2026
- FDA UDI 0eabeeb9-13a3-4bc6-bad5-e5a4461cc1ad 35 fields · synced May 30, 2026
- EUDAMED 712ea14d-2e8b-4c0c-ae89-1a328b3a2e6c 61 fields · synced Jul 15, 2026