NoFact VIII Deficient Plasma
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- NoFact VIII EUDAMEDFDA UDI
- Generic Name
- Coagulation factor VIII IVD, kit, clotting FDA UDI
- Device Name
- NoFact VIII EUDAMEDFactor VIII immunodepleted 10 x 1 ml FDA UDI
- Model / Reference
- 68-201 EUDAMEDFDA UDI
- Description
- Factor VIII immunodepleted 10 x 1 ml FDA UDI
Identifiers
- Catalog Number
- 68-201 FDA UDI
- Primary DI / UDI-DI
- 10859394006153 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10859394006153 EUDAMED
- 510(k) Number
- FDA Product Code
- GJT FDA 510(k)FDA UDI
- EMDN Code
- W0103020207 COAGULATION FACTOR VIII EUDAMED
- GMDN Term
- Coagulation factor VIII 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
NoFact VIII Deficient Plasma is a human plasma substrate immunodepleted of Factor VIII, classified as a Plasma, Coagulation Factor Deficient device under the FDA nomenclature. It is designed for the quantitative determination of Factor VIII activity in citrated patient plasma, utilising an activated partial thromboplastin time assay to measure clotting factor levels in suspected FVIII deficiency cases.
This device is supplied as a single-use, in vitro diagnostic reagent intended for laboratory use. It is authorised under FDA 510(k) clearance and IVDD compliance, with a product code of GJT and device class II classification. Sterility and storage conditions are not specified in the provided data, but it is intended for use in hematology settings where precise coagulation factor measurement is required.
Frequently asked questions
What is the NOFact VIII Deficient Plasma used for in a clinical setting?
The NOFact VIII Deficient Plasma is specifically designed for the quantitative measurement of Factor VIII activity in citrated patient plasma. It uses an activated partial thromboplastin time (APTT) assay to help diagnose and monitor suspected Factor VIII deficiencies, which is critical in hematology for assessing bleeding disorders like hemophilia.
Is the NOFact VIII Deficient Plasma intended for single-use or repeated use?
The NOFact VIII Deficient Plasma is explicitly labeled as a single-use in vitro diagnostic reagent. This means each vial is intended for one test procedure only, ensuring accuracy and preventing cross-contamination in laboratory settings.
What regulatory pathways does the NOFact VIII Deficient Plasma follow?
The NOFact VIII Deficient Plasma is authorized under both FDA 510(k) clearance and IVDD compliance, confirming its adherence to stringent regulatory standards for in vitro diagnostics. It falls under product code GJT and is classified as a Class II device, indicating moderate regulatory oversight.
What types of hematology laboratories would benefit most from using the NOFact VIII Deficient Plasma?
This reagent is ideal for specialized hematology laboratories focused on coagulation studies, particularly those diagnosing or managing Factor VIII deficiencies. Its use in APTT assays makes it valuable in clinical settings where precise measurement of clotting factors is essential, such as hemophilia treatment centers or diagnostic hematology labs.
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: PDF NoFact VIII Immunodepleted Factor VIII Deficient Substrate Plasma C E ..., NoFact Immunodepleted Plasmas - r² Diagnostics, NOFACT VIII (K102851) — FDA 510(k) | Innolitics
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 | K102851 | Class II | Active |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (3)
- FDA 510(k) K102851 24 fields · synced Sep 18, 2026
- FDA UDI 39090041-f723-4e58-a3fe-7171eb0ca9df 35 fields · synced May 30, 2026
- EUDAMED de872d61-94d3-4c95-9e76-54e902b697d5 61 fields · synced Jul 13, 2026