Haematology / haemostasis / immunohaematology / histology / cytologyHaematology reagentsHaematology controls and calibrators

Haematology controls - other

EMDN code W0103010599

22 manufacturers, 104 models including 102 on the market, 11 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 22

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
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hematology Analyzer Calibrator EBL220100298/79 Hematology Analyzer Control EBL220100398/79 Hematology Analyzer Control EBL220100498/79 Hematology Analyzer Control EBL220200298/79 Hematology Analyzer Control EBL220200398/79 20 others Hematology Analyzer Control EBL220200498/79 Hematology Analyzer Control EBL220300298/79 Hematology Analyzer Control EBL220300398/79 Hematology Analyzer Control EBL220300498/79 Hematology Analyzer Control EBL220400298/79 Hematology Analyzer Control EBL220400398/79 Hematology Analyzer Control EBL220400498/79 Hematology Analyzer Control EBL220900298/79 Hematology Control EBL229100198/79 Hematology Control EBL229100298/79 Hematology Control EBL229100398/79 Hematology Control EBL229200198/79 Hematology Control EBL229200298/79 Hematology Control EBL229200398/79 Hematology Control EBL229600198/79 Hematology Control EBL229600298/79 Hematology Control EBL229600398/79 Hematology Control EBL229700198/79 Hematology Control EBL229700298/79 Hematology Control EBL229700398/79	– 98/79	Website EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany)	China	Hematology Calibrator DM-CAL-5E 3mL×298/79 Hematology Calibrator DM-CAL-5E 3mL×198/79 Hematology Calibrator Model:DM-CAL-5E Specification:3mL×1、3mL×2、3mL×3 Hematology Calibrator Model:DM-CAL-RET ,Specification:3mL×398/79 Hematology Calibrator Model:DM-CAL-RET,Specification：3mL×1、3mL×2、3mL×32 refs 16 others Hematology Control DH-RET 3 mL×1 (H)98/79 Hematology Control DH-RET 3 mL×1 (L)98/79 Hematology Control DH-RET 3 mL×1 (N)98/79 Hematology Control DM-6D 3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×198/79 Hematology Control DM-6D 3 mL×2 (N)98/79 Hematology Control DM-6D 3 mL×3 (L)98/79 Hematology Control DM-6D 3 mL×3 (N)98/79 Hematology Control DM-BF 3 mL×2 (L)98/79 Hematology Control DM-BF 3 mL×3 (H)98/79 Hematology Control DM-BF 3 mL×3 (L)98/79 Hematology Control DM-BF 3 mL×3 (N)98/79 Hematology Control DM-RET 3 mL×1 (L)98/79 Hematology Control Model:DM-6D Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL (N)×1、3 mL(N)×2 、3 mL(N)×3 、3 mL (L)×1、3 mL(L)×2 、3 mL (L)×3、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×13 refs Hematology Control Model:DM-BF Specification:3 mL(H)×1、3 mL(H)×2、3 mL(H)×3 、3 mL(N)×1 、3 mL(N)×2 、3 mL(N)×3、、3 mL(L)×1 、3 mL (L)×2、3 mL×3 (L)、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×13 refs Hematology Control Model:DM-BF Specification:3 mL×1(H)98/79 Hematology Control Model:DM-RET Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL×(N)1 、3 mL(N)×2 、3 mL (N)×3、3 mL(L)×1 、3 mL(L)×2 、3 mL(L)×3 、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×13 refs	B IVDR, 98/79	regulationdept@dymind.com EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland)	Ireland, United States	COULTER 4C-ES Cell Control5 refs98/79 COULTER 6C Cell Control2 refs98/79 COULTER Body Fluid Control98/79 COULTER Latron CP-X Control98/79 COULTER LIN-C Linearity Controls98/79 8 others COULTER LIN-X Linearity Control98/79 Coulter Retic-C Cell Control3 refs98/79 DxH 500 Series Control B3687298/79 Latron Control 298/79 Latron Primer I98/79 SYNCHRON Systems Ammonia/Alcohol Control Level 198/79 SYNCHRON Systems Ammonia/Alcohol Control Level 298/79 SYNCHRON Systems Ammonia/Alcohol Control Level 398/79	– 98/79	Website ra.clare@beckman.com EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands)	China	Control for Automatic Hematology Analyzer (5-part) Level 1: 2.5 ml98/79 Control for Automatic Hematology Analyzer (5-part) Level 2: 2.5 ml98/79 Control for Automatic Hematology Analyzer (5-part) Level 3: 2.5 ml98/79 Control for Body Liquid Level 1: 1×3.0mL98/79 Control for Body Liquid Level 2: 1×3.0mL98/79 6 others Control for Hematology Analyzer Level 1: 2ml98/79 Control for Hematology Analyzer Level 2: 2ml98/79 Control for Hematology Analyzer Level 3: 2ml98/79 Fluorescent Control Level 1: 1×2.5mL98/79 Fluorescent Control Level 2: 1×2.5mL98/79 Fluorescent Control Level 3: 1×2.5mL98/79	– 98/79	EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	ADVIA 120/2120/2120i 3 in 1 TESTpoint CSF Controls IVDR_67_TTN_DUB-C_B_REAG_CSF Controls ADVIA 120/2120/2120i TESTpoint Hematology Controls (High) IVDR_67_TTN_DUB-C_B_REAG_Control High ADVIA 120/2120/2120i TESTpoint Hematology Controls (Low) IVDR_67_TTN_DUB-C_B_REAG_Control Low ADVIA 360 Control IVDR_67_TTN_DUB-C_B_REAG_Control2 refs Atellica HEMA Control BF (H) DX LS_LEGACY_0063041429012698/79 1 other Atellica HEMA Control BF (N) DX LS_LEGACY_0063041429011998/79	B IVDR, 98/79	Website contact@siemens-healthineers.com EUDAMED record Report an error
Microgenics FDA EU representative : B·R·A·H·M·S GmbH (Germany)	United States	HYC8466698/79 HYC8466798/79 HYC8466898/79 HYC8466998/79	– 98/79	Website EUDAMED record Report an error
Randox FDA	Northern Ireland	COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)98/79 COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)98/79 COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)98/79	– 98/79	Website EUDAMED record Report an error
Alifax FDA	Italy	LATEX CALIBRATORS SI 305.400-A2 refs LATEX CONTROLS SI 305.100-A3 refs	A IVDR	Website regulatory@alifax.com EUDAMED record Report an error
Biosystems FDA	Spain	COAGULATION CALIBRATOR2 refs98/79 COAGULATION CONTROL I/II4 refs98/79	– 98/79	Website EUDAMED record Report an error
Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Control DDDM06598/79 Kemilo D-Dimer Control2 refs98/79	– 98/79	Website export@goldsite.com.cn EUDAMED record Report an error
Horiba FDA	France	ABX Minotrol CRP 2042205, 2042206, 20422063 refs BFTROL 1300039405	B IVDR	EUDAMED record Report an error
R&D Systems FDA EU representative : BIO-TECHNE SAS (France)	United States	FETALtrol HGBF215 refs98/79 Glu/Hgb Control HEGLU216 refs98/79	– 98/79	regulatorydiagnosticsdivision@bio-techne.com EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany)	Japan	XN CHECK3 refs98/79 e-CHECK(XS)3 refs98/79 (no longer marketed)	– 98/79	ra_archive@sysmex.co.jp EUDAMED record Report an error
Alcor Scientific FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	SEDiTROL2 refs	A IVDR	EUDAMED record Report an error
Atlas Medical FDA	Germany	Atlas Sickle cell positive and negative control set. 8.02.68.0.000198/79	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Diesse FDA	Italy	ESR CONTROL ESRCTRL	A IVDR	Website EUDAMED record Report an error
Hunan Ehome Health Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Quality Control for Hematology Analyzer YH-QC50298/79	– 98/79	EUDAMED record Report an error
Institut de Biotechnologies Jacques Boy	France	IJB K-Control98/79	– 98/79	Website contact@ibjb.fr EUDAMED record Report an error
Medicon Hellas FDA	Greece	G-6-PDH3 refs	C IVDR	Website EUDAMED record Report an error
Stago FDA	France	sthemA CTR-L13 refs	B IVDR	EUDAMED record Report an error
Δημητριαδης Ιωαννης & Υιος Ικε Hellabio	Greece	Hellabio HSC013 refs	B IVDR	Website EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market	Argentina	ESR Control (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) 17

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
Eurotrol B.V. Present in Europe in other categories	Netherlands	CueSee® CO-OX Eurotrol HemoTrol Duo	K192842 (2019)
Bio-Rad Present in Europe in other categories	United States	Liquichek InteliQ Lyphochek	K070546 (2007)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.	–	Research and Diagnostic Systems	registered
Urit Medical Electronic Co., Ltd. Present in Europe in other categories	United States	Hemoglobin Control Solution Hemoglobin Test Strip Hemoglobin Meter	registered
DiaSpect Medical GmbH Present in Europe in other categories	–	DiaSpect Control Pack HBT4 DiaSpect Control Pack HBT3 DiaSpect Control Pack HBT2 DiaSpect Control Pack HBT1	registered
Ekf-Diagnostic GmbH Present in Europe in other categories	Germany	DiaSpect Control HBT4 DiaSpect Control HBT1 DiaSpect Control HBT3 DiaSpect Control HBT2	registered
Abbott Laboratories Present in Europe in other categories	United States	ARCHITECT	registered
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson	registered
GERMAINE LABORATORIES, INC	United States	AIMSTRIP HEMOGLOBIN CONTROL SET	registered
HENRY SCHEIN, INC. Present in Europe in other categories	United States	Henry Schein	registered
Immunostics Company, Inc	United States	hemochroma PLUS Control	registered
Siemens Healthcare Diagnostics Products GmbH Present in Europe in other categories	Germany	Dade® Sickle-Trol Hemoglobin Controls	registered
ACON Laboratories, Inc.	United States	–	registered
Boditech Med Inc. Present in Europe in other categories	South Korea	–	registered
Mark Enterprises	India	–	registered
STANBIO LABORATORY, L.P.	United States	–	registered
STS Corporation	United States	–	registered

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