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Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Coagulation inhibitors/thrombophilia markers

Coagulation inhibitors/thrombophilia markers for heparin induced thrombocytopenia test (hit)

EMDN code W0103020615

6 manufacturers, 12 models including 12 on the market, 4 countries

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Manufacturers registered in Europe (EUDAMED) 6
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Sysmex FDA EU representative : Sysmex Europe SE (Germany) Japan C IVDR ra_archive@sysmex.co.jp EUDAMED record Report an error
Aesku FDA Germany – 98/79 Website EUDAMED record Report an error
AIDA Germany – 98/79 EUDAMED record Report an error
HYPHEN BioMed FDA France C IVDR Website info@hyphen-biomed.com EUDAMED record Report an error
Stago FDA France – 98/79 EUDAMED record Report an error
Biokit FDA Spain B IVDR EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 5

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
IMMUCOR GTI DIAGNOSTICS, INC. Present in Europe in other categories United States PF4 Enhanced® PF4 IgG Anti-Human IgG/A/M Conjugate Specimen Diluent PF4 Concentrated Wash (10x) Negative Serum Control K201570 (2020)
Instrumentation Laboratory CO Present in Europe in other categories United States HemosIL CL HIT-IgG (PF4-H) HemosIL AcuStar HIT-IgG (PF4-H) HemosIL HIT-Ab(PF4-H) K170854 (2017)
AKERS BIOSCIENCES, INC. United States PIFA PLUSS® PF4 Rapid Assay PIFA® Heparin/PF4 Rapid Assay registered
IMMUCOR, INC. Present in Europe in other categories United States – registered
Instrumentation Laboratory (IL) Co. Present in Europe in other categories United States – K243374 (2025)

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