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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Last updated May 24, 2026

What SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD makes

The company manufactures in vitro diagnostic (IVD) reagents, controls, and kits for immunology and coagulation testing, including allergen-specific IgE antibody assays, fibrinogen assays, and multiple coagulation factor controls. It also produces nephelometry/turbidimetry kits for measuring immunoglobulin A (IgA) and albumin, as well as chromogenic kits for antithrombin III (ATIII) testing. Buffered sample diluents and heparin anti-Xa controls are part of its portfolio, alongside calibration verification materials for hormone assays.

The portfolio includes devices classified as Class I, Class II, and Class III under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Siemens Healthcare Diagnostics Products Ltd manufacture?

Siemens Healthcare Diagnostics Products Ltd specializes in in vitro diagnostic (IVD) reagents, controls, and kits. These products are primarily used for immunology and coagulation testing, such as allergen-specific IgE antibody assays, fibrinogen assays, and controls for multiple coagulation factors. The company also produces kits for measuring immunoglobulins (like IgA) and albumin using nephelometry/turbidimetry, as well as chromogenic kits for antithrombin III (ATIII) testing. Additionally, it offers buffered sample diluents and calibration verification materials for hormone assays.

Where is Siemens Healthcare Diagnostics Products Ltd based?

The company is based in the United States. This location is relevant for regulatory oversight, as the FDA’s Unique Device Identifier (UDI) database includes all its listed devices, ensuring traceability and compliance with U.S. regulatory standards.

Which regulatory registries list the devices manufactured by Siemens Healthcare Diagnostics Products Ltd?

The devices manufactured by Siemens Healthcare Diagnostics Products Ltd are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for tracking, compliance, and transparency in the medical device supply chain.

How are the devices produced by Siemens Healthcare Diagnostics Products Ltd classified under FDA regulations?

The devices produced by Siemens Healthcare Diagnostics Products Ltd are classified under three categories: Class I, Class II, and Class III. These classifications determine the regulatory controls applied to each device, with Class III typically requiring the highest level of scrutiny due to higher risk, while Class I devices generally pose minimal risk and require less stringent oversight.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: siemens-healthineers.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(877)229-3711
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 296822794

Catalogue (1070)

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Device	Model / Reference	Registries	Class	Status
IMMULITE® 2000 Systems BRM BR-MA (CA15-3)	10380983	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Red Mulberry	10386102	FDA UDI	Class II	Active
INNOVANCE Free PS Ag	10873458	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Tabacco	10386050	FDA UDI	Class II	Active
INNOVANCE® Antithrombin	10487304	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Cottonwood	10386059	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems T3 Total T3	10381630	FDA UDI	Class II	Active
IMMULITE® 2000 Systems RUM Rubella IgM	10374021	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Western Ragweed	10386151	FDA UDI	Class II	Active
IMMULITE® 2000 Systems TBG	10381660	FDA UDI	Class II	Active
IMMULITE® 2000 Systems PTH Intact PTH Sample Diluent	10387060	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Eucalyptus	10386064	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ nBet v 1	10368597	FDA UDI	Class II	Active
N Antiserum to Human Albumin	10714508	FDA UDI	Class II	Active
IMMULITE® 2000 Systems INS Insulin	10381456	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Sweet Vernal Grass	10385913	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ English Plantain	10386168	FDA UDI	Class II	Active
Coagulation Factor XI Deficient Plasma	10446316	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Perch	10385843	FDA UDI	Class II	Active
DImension Vista® Haptoglobin Flex® reagent cartridge	10445896	FDA UDI	Class II	Active
DImension Vista® Cystatin C Flex® reagent cartridge	10445895	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Chicken Meat	10385860	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Sunflower	10385998	FDA UDI	Class II	Active
N Latex ADNase B (USA)	10873691	FDA UDI	Class I	Active
Thromborel® S	10446442	FDA UDI	Class II	Unknown
IMMULITE® 2000 Systems PRL Prolactin Sample Diluent	10387069	FDA UDI	Class I	Active
Factor V Leiden	10873903	FDA UDI	Class II	Active
N Antisera to Human IgA	10446295	FDA UDI	Class II	Active
DImension Vista® Immunoglobulin E Flex® reagent cartridge	10445902	FDA UDI	Class II	Active
Dade Innovin	10873933	FDA UDI	Class II	Active
Dade® Thrombin Reagent	10445720	FDA UDI	Class II	Active
N Evaporation Caps for Control Vials (2.5 mL)	10446534	FDA UDI	Class I	Active
IMMULITE®/IMMULITE® 1000 Systems GAS Gastrin Sample Diluent	10386986	FDA UDI	Class I	Active
IMMULITE®/IMMULITE® 1000 Systems TU Thyroid Uptake	10381619	FDA UDI	Class II	Active
N Apolipoprotein Standard Serum	10446466	FDA UDI	Class II	Active
IMMULITE® 2000 Systems DHS DHEA-SO4	10381193	FDA UDI	Class I	Active
IMMULITE Systems Unconjugated Estriol (uE3) CVM	10707265	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Wild Rye Grass	10385925	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Egg White	10385704	FDA UDI	Class II	Active
IMMULITE® 2000 Systems PHN Phenytoin	10381548	FDA UDI	Class II	Active
Dade® Fibrinogen Determination Reagents	10445718	FDA UDI	Class II	Unknown
IMMULITE®2000 Systems 3gAllergy™ Lettuce	10385719	FDA UDI	Class II	Active
IMMULITE® 2000 Systems PRG Progesterone	10381170	FDA UDI	Class I	Active
N Antiserum to Human Haptoglobin	10446304	FDA UDI	Class II	Active
IMMULITE® Systems PAP CONTROL PAP	10385588	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Food Panel 1	10385882	FDA UDI	Class II	Active
N FLC Standard SL	10482440	FDA UDI	Class II	Active
IMMULITE® 2000 Systems HCY Homocysteine Sample Diluent	10387055	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems ACT ACTH	10381415	FDA UDI	Class II	Active
N Antiserum to Human Prealbumin	10446452	FDA UDI	Class I	Active

Related Companies

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FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Siemens Healthcare Diagnostics Products Limited LLANBERIS Wales · GB FEI 3002806944
Siemens Healthcare Diagnostics Products GmbH MARBURG Hesse · DE FEI 3001644026