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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™ Helminthosporium halodes	10386045	FDA UDI	Class II	Active
Dade Ci-Trol Coagulation Control Level 1	10873842	FDA UDI	Class II	Active
N Antisera to Human IgG	10446299	FDA UDI	Class II	Active
Coagulation Factor VII Deficient Plasma	10873879	FDA UDI	Class II	Active
Dade® Ci-Trol® Coagulation Control Level 3	10445733	FDA UDI	Class II	Active
IMMULITE® Systems TBG CONTROL	10385244	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Rat Epithelium	10385658	EUDAMEDFDA UDI	Class II	Active
Dade® Thrombin Reagent	10445721	FDA UDI	Class II	Active
IMMULITE® 2000 Systems HCG	10381206	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Food Panel 6	10385899	FDA UDI	Class II	Active
IMMULITE Systems Rubella Quantitative IgG CVM	10388114	FDA UDI	Class I	Active
Dade® Sickle-Sol Test	10459402	FDA UDI	Class II	Active
Atellica IM Tg	11200450	FDA UDI	Class II	Active
IMMULITE® 2000 Systems BcM Anti-HBc IgM	10488616	FDA UDI	Class II	Active
Dade Data-Fi Abnormal Fibrinogen Control	10873836	EUDAMEDFDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Saltbush	10386153	FDA UDI	Class II	Active
Atellica IM HBcT2 QC	11200740	FDA UDI	Class II	Active
IMMULITE® 2000 Systems TT4 Total T4	10381685	FDA UDI	Class II	Active
IMMULITE®/IMMULITE®1000 Systems aBC Anti-HBc	10370305	FDA UDI	Class II	Unknown
N Latex RF Kit	10445992	FDA UDI	Class II	Active
Dade® Innovin®	10445705	FDA UDI	Class II	Unknown
IMMULITE®/IMMULITE® 1000 Systems COR Cortisol Sample Diluent	10386981	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Cheddar Cheese	10385858	FDA UDI	Class II	Active
IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2	10485105	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Guinea Pig Epithelium	10385654	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Rough Marsh Elder	10386137	FDA UDI	Class II	Active
Dade® Innovin®	10873567	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Pine Nut	10385746	FDA UDI	Class II	Active
IMMULITE® Systems CAL Calibration Verification Material Calcitonin	10373685	FDA UDI	Class I	Active
IMMULITE® 2000 Systems TSH Third Generation TSH	10381667	FDA UDI	Class II	Active
vWF Ag	10873845	FDA UDI	Class II	Active
N FLC Supplementary Reagent	10482439	FDA UDI	Class II	Active
Dimension Vista® Flex® reagent cartridge A2MAC	10465670	FDA UDI	Class II	Unknown
IMMULITE®2000 Systems 3gAllergy™ Mesquite	10386070	FDA UDI	Class II	Active
IMMULITE® Systems CONTROL Calcitonin	10385383	FDA UDI	Class II	Active
IMMULITE® 2000 Systems T3 Total T3	10381654	FDA UDI	Class II	Active
IMMULITE®/IMMULITE®1000 Systems BcM Anti-HBc IgM	10488615	FDA UDI	Class II	Unknown
IMMULITE®2000 Systems 3gAllergy™ Nettle	10386146	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol Sample Diluent	10387021	FDA UDI	Class I	Active
IMMULITE® 2000 Systems TG Thyroglobulin	10381647	FDA UDI	Class II	Active
N Antiserum to Human Transferrin	10446308	FDA UDI	Class II	Active
IMMULITE® 2000 Systems TIE Total IgE	10380872	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Imported Fire Ant	10385960	FDA UDI	Class II	Active
Dimension Vista® Rheumatoid Factors Flex® reagent cartridge	10445908	FDA UDI	Class II	Active
IMMULITE 2000 nPru p 3 Specific Allergen	10368596	EUDAMEDFDA UDI	Class II	Active
Coagulation Factor II Deficient Plasma	10873878	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin Sample Diluent	10387046	FDA UDI	Class II	Active
IMMULITE® 2000 Systems TIE Total IgE	10380873	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Japanse Cedar	10386063	EUDAMEDFDA UDI	Class II	Active
Berichrom® Heparin UF Control 1	10445985	FDA UDI	Class II	Unknown

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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