ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaematology reagents

Haemoglobin (types) testing

EMDN code W01030102

36 manufacturers, 96 models including 89 on the market, 15 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 36

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
Sanymed	Italy	Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) BT Line R1: 1x50mL + LYSE: 4x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) Bulk R1: 1x1000mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) MULTI-PURPOSE KIT R1: 1x50mL + LYSE: 4x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) SA1500/2500 R1: 1x40mL + LYSE: 1x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) SA2000 R1: 1x35mL + LYSE: 4x45mL98/79 6 others Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) SA3500/4500/330 L Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) SA3500/4500/330 R1: 1x50mL + LYSE: 1x45mL98/79 Hb - Emoglobina Totale / Total Hemoglobin (Colorimetric) Sphera R1: 1x50mL + LYSE: 4x45mL98/79 Hb Ctrl - Emoglobina Totale CTRL 2Liv./ Total Hemoglobin CTRL 2Lev. Bulk CTL:1000mL98/79 Hb Ctrl - Emoglobina Totale CTRL 2Liv./ Total Hemoglobin CTRL 2Lev. MULTI-PURPOSE KIT CTL1:1x3mL + CTL2:1x3mL98/79 Hb STD - Emoglobina Totale STD / Total Hemoglobin STD Bulk STD:1000mL98/79 Hb STD - Emoglobina Totale STD/ Total Hemoglobin STD MULTI-PURPOSE KIT STD:1x5mL98/79	– 98/79	Website info@sanymed.it EUDAMED record Report an error
Ailex EU representative : CMC Medical Devices & Drugs SL (Spain)	China	150Tests98/79 200Tests98/79 Calibrator 1～2：2×0.1mL98/79 Calibrator 1～2：2×0.2mL98/79 Control1～2：2×0.2mL98/79 5 others Control1～2：4×0.2mL98/79 Eluent1: 800mL×1bag98/79 Eluent2: 800mL×1bag98/79 Eluent3: 800mL×1bag98/79 Hemolysis & Wash Solution:2L×1bottle98/79	– 98/79	EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	Haemoglobin (Ready to Use) 611 00198/79 Haemoglobin (Ready to Use) 611 00298/79 Haemoglobin (Ready to Use) 611 00398/79 Haemoglobin (Single Reagent) 610 00198/79 Haemoglobin (Single Reagent) 610 00298/79 2 others Haemoglobin Drabkin’s Solution 612 00198/79 Haemoglobin Drabkin’s Solution 612 00298/79	– 98/79	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium)	Belgium, Japan	GR F&A2 Calibrator Set GR01 β-Thalassemia Elution Buffer No. 13 refs Hemolysis Collection System 10 µL Hemolysis Stability Solution 6 x 100 ml TSKgel GR01 β-Thal.	A, B IVDR	Website csc@tosoh.co.jp EUDAMED record Report an error
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇	Türkiye	HbA1c Kit 138mL98/79 HbA1c Kit 276mL98/79 HbA1c Kit 511mL98/79 HbA1c Kit HbA1c+Lyse Kit 520mL98/79	– 98/79	info@kinetikkimya.com EUDAMED record Report an error
LaCAR MDx Technologies FDA	Belgium	Targeted MS/MS Hemo screening assay J-LS-480PartA98/79 Targeted MS/MS Hemo screening assay J-LS-480PartB98/79 Targeted MS/MS Hemo screening assay J-LS-96PartA98/79 Targeted MS/MS Hemo screening assay J-LS-96PartB98/79	– 98/79	Website EUDAMED record Report an error
Seleo	Italy	Hemoglobin electrophoresis kit 100 tests 4 samples98/79 Hemoglobin electrophoresis kit 200 tests98/79 Hemoglobin electrophoresis kit 200 tests 4 samples98/79 Hemoglobin electrophoresis kit 80 tests98/79	– 98/79	Website EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	Haemoglobin (Ready To Use)3 refs98/79 Haemoglobin (Single Reagent)2 refs98/79 Haemoglobin Drabkin's Solution2 refs98/79 Hemoglobin (Ready-To-Use)Drabkin’s Solution2 refs98/79	– 98/79	Website EUDAMED record Report an error
Zentech FDA	Belgium	J-LS-480PartA98/79 J-LS-480PartB98/79 J-LS-96PartA98/79 J-LS-96PartB98/79	– 98/79	EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	Haemoglobin (Ready-To-Use) Drabkin's Solution4 refs98/79 Haemoglobin (Single Reagent) Drabkin’s Solution2 refs98/79 Haemoglobin Drabkin’s Solution2 refs98/79	– 98/79	EUDAMED record Report an error
Biolabo	France	HAEMOGLOBIN Colorimetric Method (Cyanmethemoglobin) HbA1c Standard Set	B, C IVDR	support@biolabo.fr EUDAMED record Report an error
Gc Medis EU representative : Obelis s.a. (Belgium)	South Korea	CERA-CHEK™ 3 in 1 GHL Hemoglobin Test Strip M 40098/79 CERA-CHEK™ Hb Plus Hemoglobin Test Strip H 40098/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Hb Hemoglobin Test Strip OHBS-41198/79 Sickle cell Rapid Test OSCD-40298/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Hunan Hehao Medical Technology EU representative : Lotus NL B.V. (Netherlands)	China	Fecal Occult Blood (FOB) Test Kit (LIA)2 refs98/79 Fecal Occult Blood (FOB) Test Kit (LIA) Hitachi 7020, 7180, Beckman AU680,OC-Sensor IO2 refs	B IVDR, 98/79	EUDAMED record Report an error
IQ Products FDA	Netherlands	Fetal Cell Count™ kit98/79 FMH QuikQuant98/79	– 98/79	Website orders@iqproducts.nl EUDAMED record Report an error
Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HbA1c calibrator 2×0.1mL98/79 HbA1c Control Material 2×0.1mL98/79	– 98/79	Website EUDAMED record Report an error
Rapid Labs EU representative : VidaQuick Biotech S.L. (Spain)	United Kingdom (ex Northern Ireland)	HB Hemoglobin Strip D-HBMS5098/79 Sickle Cell Rapid Test Device-WB98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Wells Bio EU representative : MDSS GmbH (Germany)	South Korea	BHP-E0258298/79 BSH-E0258298/79	– 98/79	Website info@wellsbio.net EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	Mission CCS-1712 refs98/79	– 98/79	Website EUDAMED record Report an error
Acro Biotech FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	Sickle Cell Rapid Test OSCD-ACO40298/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	Sickle Cell Rapid Test SCD-2-D98/79	– 98/79	info@actest.com.cn EUDAMED record Report an error
Biosense EU representative : MD&D Alliance GmbH (Germany)	India	HbChek	A IVDR	regulatory.affairs@biosense.in EUDAMED record Report an error
Chengdu Polytech Biological Technology EU representative : MedNet EC-REP GmbH (Germany)	China	tHb Kit(Colorimetry)98/79	– 98/79	EUDAMED record Report an error
Chronolab	Spain	Hemoglobin 50X, R: 4 x 5 mL, CAL: 1 x 1 mL98/79	– 98/79	Website info@chronolab.com EUDAMED record Report an error
Eschweiler	Germany	ESCHWEILER Sensor tHb98/79	– 98/79	Website info@eschweiler-kiel.de EUDAMED record Report an error
FAR	Italy	HEMOGLOBIN A298/79	– 98/79	order@fardiag.com EUDAMED record Report an error
Helena Biosciences Europe FDA EU representative : Prince Technologies (Netherlands)	United Kingdom (ex Northern Ireland)	V8 Haemoglobin UltraScreen Kit 80110098/79	– 98/79	Website EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Card type98/79	– 98/79	Website EUDAMED record Report an error
Hotgen FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Glycosylated Hemoglobin test (Chemiluminescence Immunoassay) Please see the IFU	C IVDR	service@hotgen.com.cn EUDAMED record Report an error
Human	Germany	HEMOGLOBIN liquicolor98/79	– 98/79	Website EUDAMED record Report an error
Ing. Petr Švec - PENTA s.r.o	Czechia	DRABKIN ROZTOK	A IVDR	Website info@pentachemicals.eu EUDAMED record Report an error
Linear FDA	Spain	Cromatest4 refs98/79	– 98/79	Website info@linear.es EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	Hemoglobin Test strip C41-HBB498/79	– 98/79	Website info@kylinew.com EUDAMED record Report an error
Spinreact	Spain	HEMOGLOBIN No98/79	– 98/79	Website EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	Sickle Cell Rapid Test O027-400298/79	– 98/79	EUDAMED record Report an error
Vitro Scient EU representative : MDSS GmbH (Germany) No model still on the market	Egypt	Hemoglobin ( 1 + 9 ) 4 x 100 ml - 1240198/79 (no longer marketed) Hemoglobin ( 1 + 99 ) 1 x 25 ml - 1280198/79 (no longer marketed) Hemoglobin ( 1 + 99 ) 10 x 25 ml - 1280498/79 (no longer marketed) Hemoglobin ( 1 + 99 ) 2 x 25 ml - 1280298/79 (no longer marketed) Hemoglobin ( 1 + 99 ) 5 x 25 ml - 1280398/79 (no longer marketed) 2 others Hemoglobin (Ready for use) 1 x 500 ml - 1270198/79 (no longer marketed) Hemoglobin (Ready for use) 2 x 500 ml - 1270298/79 (no longer marketed)	– 98/79	Website info@vitroscient.com EUDAMED record Report an error

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