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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 3gAllergy™ Turkey Meat	10385774	FDA UDI	Class II	Active
IMMULITE® Systems FER Calibration Verification Material Ferritin	10387969	FDA UDI	Class I	Active
Diff-Quik™ Stain Set	10459382	FDA UDI	Class I	Unknown
LA Control Low	10873935	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ White Mulberry	10386101	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Rice	10385877	FDA UDI	Class II	Active
IMMULITE® Systems F4 Calibration Verification Material Free T4	10373691	FDA UDI	Class I	Active
IMMULITE®/IMMULITE® 1000 Systems ALB Albumin	10381385	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems GH Growth Hormone Sample Diluent	10387030	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Orchard Grass	10385919	FDA UDI	Class II	Active
IMMULITE 2000 DHEAS Kit Domestic 200T	10901849	FDA UDI	Class I	Active
IMMULITE® Systems PRL Calibration Verification Material Prolactin	10388107	FDA UDI	Class I	Active
IMMULITE Systems High Sensitivity CRP CVM	10373686	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Brazilian Peppertree	10386088	FDA UDI	Class II	Active
IMMULITE® 2000 Systems TGB TBG Sample Diluent	10387072	FDA UDI	Class II	Active
IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent	10385353	FDA UDI	Class I	Active
BCS® System Cuvette Rotors	10446524	FDA UDI	Class II	Active
Immulite® 2000 Tsi	10876421	FDA UDI	Class II	Active
IMMULITE 2000/XPi Probe Wash Module	10385231	FDA UDI	Class I	Active
N Latex CDT Kit	10445997	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Cultivated Oat Gras	10385909	FDA UDI	Class II	Active
DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin	10445894	FDA UDI	Class II	Active
Dade Innovin	10873932	FDA UDI	Class II	Active
INNOVANCE Apixaban Controls	10874082	FDA UDI	Class II	Active
Thromborel® S	10446445	FDA UDI	Class II	Unknown
INNOVANCE Heparin LMW Control 2	10873533	FDA UDI	Class II	Active
IMMULITE® 2000 Systems AF AFP	10381184	FDA UDI	Class III	Active
IMMULITE®/IMMULITE® 1000 Systems CMV IgM	10370301	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Brewers Yeast	10385818	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Scallop	10385801	EUDAMEDFDA UDI	Class II	Active
IMMULITE® 2000 Systems LH	10381212	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Penicillium notatum	10386019	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Lima Bean	10385700	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Chili-Pepper	10385769	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems RHC Turbo HCG	10381169	FDA UDI	Class II	Unknown
IMMULITE®2000 Systems 3gAllergy™ Cinnamon	10385725	FDA UDI	Class II	Active
Coagulation Factor X Deficient Plasma	10873882	FDA UDI	Class II	Active
N Protein Standard SL	10446073	FDA UDI	Class II	Active
Cleaner SCS	10446136	FDA UDI	Class I	Active
INNOVANCE Anti-Xa	10873942	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ White Pine	10386061	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Euroglyphus maynei	10385639	FDA UDI	Class II	Active
Dade® Ci-Trol® Coagulation Control Level 2	10445732	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Epicoccum purpurascens	10386015	FDA UDI	Class II	Active
IMMULITE® INS Control Insulin	10286614	FDA UDI	Class I	Active
Dimension Vista® Flex® reagent cartridge KAPPA	10465671	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Yellow Hornet	10385958	FDA UDI	Class II	Active
DImension Vista® Immunoglobulin G Subclass 4 Flex® Reagent Cartridge	10445914	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Egg Pineapple	10385715	FDA UDI	Class II	Active
INNOVANCE Antithrombin	10873910	FDA UDI	Class II	Active

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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