Chemistry / immunochemistry instrumentsImmunochemistry instrumentsLimited panel immunochemistry analysers

Limited panel immunochemistry analysers - consumables

EMDN code W0201020285

2 manufacturers, 13 models including 13 on the market, 2 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 2

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
RefLab	Denmark	Acidic clean for Histareader2 refs Diluent (NaOH), 1 L2 refs IL-3, 0,1 µg3 refs Lysis reagent (HClO4 - 7%), 10 mL OPA Disc 25 mg, 100 pcs3 refs 5 others Pipes buffer 1 L3 refs Reagent kit RLA700 Stop reagent (HClO4) 1 L2 refs Stripping buffer 1 L2 refs Wash buffer 200 mL3 refs	A IVDR	Website info@reflab.dk EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA	Germany	N Cuvette Segments for BN ProSpec IVDR_27_MAR EB_A_BN_PS_Cuv N Evaporation Caps for Control Vials (2.5 mL) IVDR_27_MAR EB_A_N_Eva_Caps2 refs N Predilution Wells IVDR_27_MAR EB_A_N_Predil_Well	A IVDR	Website contact@siemens-healthineers.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
Roche Diagnostics Corp. Present in Europe in other categories	United States	Tinaquant IgG Gen2 IGG Immunoglobulin G Turbidimetric) Tina-quant IgG Gen.2	K050113 (2005)
Abbott Laboratories Present in Europe in other categories	United States	ARCHITECT Alinity	K983221 (1998)
Randox Laboratories, Ltd. Present in Europe in other categories	United Kingdom	IgG	K955798 (1996)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD Present in Europe in other categories	–	Poly Rb a Hu Alpha-1-Antitrypsin Poly Rb A-Hu IgG Poly Rb A-Hu IgA, IgG, IgM	registered
Beckman Coulter, Inc. Present in Europe in other categories	United States	Synchron	registered
bioMerieux, Inc. Present in Europe in other categories	United States	VIDAS® VIDAS® PC SOFTWARE V4.9	registered
HORIBA ABX SAS Present in Europe in other categories	France	Yumizen C1200 Immunoglobulin G	registered
Kamiya Biomedical Co. Present in Europe in other categories	United States	K-ASSAY® IgG Reagent	K993281 (1999)
Kent Laboratories, Inc.	United States	Antiserum to Human IgG (gamma chain specific)	K790702 (1979)
Agilent Technologies, Inc. Present in Europe in other categories	United States	–	registered
BIT Analytical Solutions GmbH	Germany	–	registered
Diamond Diagnostics Inc. Present in Europe in other categories	United States	–	registered
Nittobo Medical Co., Ltd.	Japan	–	registered
Roche Diagnostics Operations Inc.	United States	–	registered
Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories	United States	–	registered
Thermo Fisher Scientific Present in Europe in other categories	United States	–	registered
Zeus Scientific, Inc. Present in Europe in other categories	United States	–	K924197 (1992)

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