ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHistology/cytology reagents

Cytochemical staining reagents

EMDN code W01030702

13 manufacturers, 30 models including 30 on the market, 8 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 13

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
Lituo EU representative : CMC Medical Devices & Drugs SL (Spain)	China	EA-503 refs EA50/OG6 Combo3 refs Gram Stain Kit Model Ⅰ, Model Ⅱ, Model Ⅲ, Model Ⅳ, Model Ⅴ3 refs HE Stain Kit Hematoxylin3 refs 4 others Iodine Solution（Lugol's Solution）3 refs Leucorrhoea Staining Solution3 refs OG-63 refs Pap Stain Kit Type A: 250ml3/Kit, 500ml3/Kit, 1L3/Kit; Type B: 250ml2/Kit, 500m12/Kit, 1L2/Kit; Type C: 250ml2/Kit, 500m12/Kit, 1L*2/Kit3 refs	A IVDR	Website EUDAMED record Report an error
RAL Diagnostics FDA	France	Kit HistoPerls 361850-0000 Kit HémaPerls 362800-0000 Kit Myeloperoxydase 361610-0000 Kit Vita-Eosine 380420-0000 Pyronin, 0,2% in aqueous solution 361800-0125	A IVDR	Website info@ral-diagnostics.fr EUDAMED record Report an error
Tianjin Bai Lixin Bio-tech EU representative : Kingsmead Service B.V. (Netherlands)	China	Eosin Stain Hematoxylin and Eosin (H&E) stain Papanicolaou Stain A Hematoxylin Solution Papanicolaou Stain D EA/OG	A IVDR	Website EUDAMED record Report an error
Dirui FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	FE Dye 1. Dye A: 1×50mL/bottle; Dye B: 1× 50mL/bottle 2. Dye A: 1×100mL/bottle, Dye B: 1×100mL/bottle 3. Dye A: 1×200mL/bottle, Dye B: 1×200mL/bottle 4. Dye A: 1×400mL/bottle, Dye B: 1×400mL/bottle 5. Dye A: 1×500mL/bottle, Dye B: 1×500mL/bottle2 refs UA Dye 100mL/bottle, 150mL/bottle2 refs	A IVDR	EUDAMED record Report an error
Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Staining Solution for Urine Analysis UFL-61 Staining Solution for Urine Analysis UFL-70、UFL-60	A IVDR	Website service@uritest.com EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue98/79	– 98/79	EUDAMED record Report an error
BioGnost	Croatia	LeukoGnost ACP, za 50 testiranja3 refs	A IVDR	Website EUDAMED record Report an error
FertiPro FDA	Belgium	LeucoScreen Plus LEUCO_PLUS3 refs	B IVDR	Website info@fertipro.com EUDAMED record Report an error
Guangzhou Hearty Expression Medical Technology EU representative : Everbiz GmbH (Germany)	China	Immunol Fluorescence Staining Kit	A IVDR	EUDAMED record Report an error
Ing. Petr Švec - PENTA s.r.o	Czechia	MUCIKARMÍN	A IVDR	Website info@pentachemicals.eu EUDAMED record Report an error
Microgenics FDA EU representative : B·R·A·H·M·S GmbH (Germany)	United States	962000A98/79	– 98/79	Website EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	INDICAID™ Vaginal Discharge Analysis Test Strip98/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium)	China	DD Nucleic Acid Dye	A IVDR	Website EUDAMED record Report an error

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