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NoFact VIII Deficient Plasma

by R 2 Diagnostics, Inc.

510(k) K102851Ref 68-201

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K102851↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-10859394006153 Basic UDI-DI 10859394006153UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10859394006153 UDI-DI Date15 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK102851 Date19 Dec 2011ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10859394006153 registered 20 May 2026 Active
  • FDA 510(k) K102851 decided 19 Dec 2011 Active
  • FDA GUDID UDI-DI 10859394006153 listed 15 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K102851
  2. Listed FDA GUDID 10859394006153
  3. Registered EUDAMED B-10859394006153

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Full name
Nofact VIII
Generic name
Coagulation factor VIII IVD, kit, clotting
Model / Ref / Catalog
68-201
FDA applicant
R2 Diagnostics, Inc.
Primary DI / UDI-DI
10859394006153
Basic UDI-DI
B-10859394006153
510(k) Number
FDA product code
GJT
EMDN code
W0103020207 Coagulation factor VIII
GMDN term
Coagulation factor VIII IVD, kit, clotting
Device class
Class IVD General EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 864.7290
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IVD General
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K102851

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K102851
UDI-DISize and differences
NoFact VIII 68-201
r2 Diagnostics Inc.
68-201 / 68-20110859394006153 —On the market

Similar devices in this category

Other devices filed under COAGULATION FACTOR VIII.

Other devices from R 2 Diagnostics, Inc.

See all devices from R 2 Diagnostics, Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)