ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaematology reagents

Haematology reagents - other

EMDN code W01030199

21 manufacturers, 57 models including 56 on the market, 12 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 21

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.

Manufacturer	Country	Registered models	Class	Contact
Biodatacorp EU representative : mdi Europa GmbH (Germany)	United States	ADP Reagent AGG/PAK™ 5 Combo Kit AggRecetin Reagent2 refs Arachidonic Acid Reagent Beta/Pak Combo Kit 9 others Calcium Chloride Solution (0.025 M) Collagen Reagent (Soluble Calf Skin, Type 1) Epinephrine Reagent Par/Pak II Combo Kit Sodium Citrate (0.11 M) TRIS Buffered Saline vW Abnormal Control Plasma vW Normal Control Plasma vW Normal Reference Plasma	A IVDR	Website customer.service@biodatacorp.com EUDAMED record Report an error
RAL Diagnostics FDA	France	Alphanaphtol solution 320750-0030 BUFFER-RAL 555 361645-0200 Formalin / Ethanol solution 310850-0125 Hydrogen peroxide 3% pH=6.8 Buffer Solution for Hematology 330368-5000 5 others pH=6.8 Buffer Solution for SP automated systems 75040SX50002 refs pH=7,2 Buffer Solution for SP automated systems 75060SX50002 refs pH=7.0 Buffer Solution for Hematology 330370-5000 pH=7.0 Buffer Solution for SP automated systems 75050SX50002 refs SP Cleaning Solution 75072SX5000	A IVDR	Website info@ral-diagnostics.fr EUDAMED record Report an error
Chrono-log FDA EU representative : BioTop Medical (Netherlands)	United States	CHRONO-LOG® Tris Buffered Saline3 refs CHRONO-LOG° Hemostasis Reference Plasma Abnormal3 refs CHRONO-PAR® Arachidonic Acid CHRONO-PAR® CHRONO-LUME® CHRONO-PAR® Collagen	A IVDR	Website regulatory@chronolog.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	Hemoglobin (HB) Test Kit (Dry Chemistry) 1 Test/Kit98/79 Hemoglobin (HB) Test Kit (Dry Chemistry) 25 Tests/Kit98/79 Hemoglobin (HB) Test Kit (Dry Chemistry) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Cellomics (Shenzhen) EU representative : Lotus NL B.V. (Netherlands)	China	Sample Separation Media CTCP0003 Sample Separation Media CTCP0006 Sample Separation Media CTCP0007	A IVDR	EUDAMED record Report an error
Ing. Petr Švec - PENTA s.r.o	Czechia	HAYEM ROZTOK KYSELINA PIKROVÁ nasycený vodný roztok LOWY ROZTOK	A IVDR	Website info@pentachemicals.eu EUDAMED record Report an error
Kolasa Spółka Jawna	Poland	Cytrynian trisodowy 3,2% 100ml3 refs Odczynnik Ehrlicha 100ml3 refs	A IVDR	EUDAMED record Report an error
Quimica Clinica Aplicada	Spain	HAYEM (1 x 500mL) TÜRK (1 x 500mL)	A IVDR	Website EUDAMED record Report an error
Wallac	Finland	JB-2 Staining System RESOLVE Hb Elution Solution2 refs	A IVDR	Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands)	China	H56 LD-I H56 LD-II	A IVDR	PMS@zy-ivd.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany)	United States	Alinity8 refs	A IVDR	Website EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	Mission 3D Hematology Reagent (Cyto-Diluent)3 refs	A IVDR	Website EUDAMED record Report an error
Bio-Gram Diagnostics FDA	Germany	JetBuffer pH 6.43 refs	A IVDR	Website contact@bio-gram.de EUDAMED record Report an error
Diagnostics	Belgium	Türk HS011	A IVDR	Website EUDAMED record Report an error
Labex	Sweden	Diluent CD3 refs	A IVDR	Website EUDAMED record Report an error
Precision for Medicine FDA EU representative : QbD RepS BV (Belgium)	United States	AAV5 NAb Test C2201301EU98/79	– 98/79	Website EUDAMED record Report an error
Rrmechatronics FDA	Netherlands	RPI-Check 1L	A IVDR	Website support@rrmechatronics.com EUDAMED record Report an error
Sysmex Europe SE FDA	Germany	SP-Buffer pH 7.02 refs	A IVDR	eudamedsupport@sysmex-europe.com EUDAMED record Report an error
Thermofisher FDA	Finland	HbA1c Pretreatment Liquid2 refs	A IVDR	Website EUDAMED record Report an error
Vitro FDA	Spain	master diagnóstica MAD-003994BP-2	C IVDR	Website regulatory@vitro.bio EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market	Argentina	Anticoagulante W (no longer marketed)	A IVDR	Website marketing@wiener-lab.com 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) 8

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.

Manufacturer	Country	Brands	FDA clearance
Helena Laboratories	United States	Plateletworks Arachidonic Acid Kit ADP Reagent Collagen Reagent Epinephrine Reagent Platelet Aggregation Kit	K061991 (2007)
TCOAG IRELAND LIMITED Present in Europe in other categories	Ireland	Ristocetin (7.5 mg/vial)	registered
AVANTOR PERFORMANCE MATERIALS, LLC Present in Europe in other categories	United States	–	registered
Chaptec America	Canada	–	registered
Ethos Biosciences	United States	–	registered
MEDICAL CHEMICAL CORPORATION	United States	–	registered
Noul Co., Ltd. Present in Europe in other categories	South Korea	–	registered
VOLUSOL	United States	–	registered

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