Skip to content

HemosIL Factor XII Deficient Plasma

by Instrumentation Laboratory CO

510(k) K180486Ref 0020011200

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

CE IVDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 21 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180486↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number8426950479277A7 Basic UDI-DI 08426950479277UDI-DIDate23 Apr 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK180486 Date22 Mar 2018ClearedStatusActive
United StatesGUDID listing GUDID Number08426950479277 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 21 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
HemosIL Factor XII deficient plasma EUDAMED
HemosIL Factor XII Deficient Plasma (10 X 1 mL) GUDID
Generic Name
Coagulation factor XII IVD, kit, clotting
Model / Ref / Catalog
0020011200 EUDAMED
00020011200 GUDID
Primary DI / UDI-DI
08426950479277
Basic UDI-DI
8426950479277A7
Direct Marketing DI
08426950479277
510(k) Number
FDA Product Code
GJT
EMDN Code
W0103020211 Coagulation factor XII
GMDN Term
Coagulation factor XII IVD, kit, clotting
Device Class
Class B EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 864.7290
EU market of registration
Italy
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
0020011200
510(k)
—
GUDID
00020011200
Device ClassEUDAMED
Class B
510(k)
Class II
GUDID
Class II

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.

The HemosIL Factor XII Deficient Plasma is a coagulation factor-deficient plasma used for in vitro diagnostic testing. It serves as a reference material in laboratory assays to evaluate coagulation factor XII activity, aiding in the diagnosis and monitoring of hemophilia-related conditions and other coagulation disorders.

This plasma is supplied as a liquid reagent for use in automated coagulation analyzers and is intended for single-use in clinical hematology settings. It is classified as a Class II device under FDA regulations and is authorized for use in the United States via FDA 510(k) clearance and the In Vitro Diagnostic Regulation (IVDR). Sterility and stability are ensured through validated manufacturing processes, with storage requirements specified for refrigeration to maintain integrity.

Other devices from Instrumentation Laboratory Company

See all devices from Instrumentation Laboratory Company →

Questions

AI-generated answers, 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.

  • What is the primary use of the HemosIL Factor XII Deficient Plasma in a clinical setting?

    The HemosIL Factor XII Deficient Plasma is used as a reference material in coagulation assays to measure Factor XII activity. It helps laboratories diagnose and monitor hemophilia-related conditions and other coagulation disorders by providing a standardized control for testing in automated coagulation analyzers.

  • Is this product intended for single-use or repeated use in a clinical environment?

    This product is explicitly designed for single-use only in clinical hematology settings. It is supplied as a liquid reagent for automated coagulation analyzers, ensuring each vial remains uncontaminated and reliable for one diagnostic test.

  • How should the HemosIL Factor XII Deficient Plasma be stored to maintain its integrity?

    The product must be stored under refrigeration to preserve sterility and stability. Proper refrigeration prevents degradation and ensures accurate coagulation testing results when used as intended.

  • What regulatory pathways does this device follow for market authorization?

    The HemosIL Factor XII Deficient Plasma is authorized in the U.S. via FDA 510(k) clearance (K180486) and complies with the In Vitro Diagnostic Regulation (IVDR). It is classified as a Class II device under FDA regulations, with a special clearance type and a hematology advisory committee review.

Properties

  • Human Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No