Is this your brand? Sign in to claim ownership.

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)

Page 2 of 22

Device	Model / Reference	Registries	Class	Status
IMMULITE®/IMMULITE® 1000 Systems TSH Third Generation TSH	10381627	FDA UDI	Class II	Active
IMMULITE® 2000 Systems CEA	10380994	FDA UDI	Class II	Active
IMMULITE® Systems CEA Calibration Verification Material	10373684	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ nCan f 1	10360570	FDA UDI	Class II	Active
DImension Vista® Immunoglobulin A Flex® reagent cartridge	10445901	FDA UDI	Class II	Active
N Latex IgM	10446035	FDA UDI	Class II	Active
N Antiserum to Human Apolipoprotein B	10446287	FDA UDI	Class II	Active
BC von Willebrand Reagent	10714565	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Parrot Feather	10385675	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Canary Grass	10385926	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Honey Bee Venom	10385950	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Hazelnut	10385699	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Ginger	10385762	FDA UDI	Class II	Active
INNOVANCE Apixaban Standard	10874083	FDA UDI	Class II	Active
IMMULITE® Systems DHS Calibration Verification Material DHEA-SO4	10387935	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Beech	10386098	FDA UDI	Class II	Active
Dimension Vista®a1-Antitrypsin Flex® reagent cartridge	10445884	FDA UDI	Class II	Active
N Latex HCY	10445973	FDA UDI	Class II	Active
IMMULITE® 2000 Systems IPT Intact PTH	10381441	FDA UDI	Class II	Active
IMMULITE/IMMULITE 1000 Systems ATG Anti-TG Ab	10381641	FDA UDI	Class II	Active
IMMULITE® Systems HCG CONTROL HCG	10385358	FDA UDI	Class II	Active
DImension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge	10445912	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Onion	10385830	FDA UDI	Class II	Active
N FLC Control SL1	10482441	FDA UDI	Class II	Active
Dade® Actin® Activated Cephaloplastin Reagent	10445709	FDA UDI	Class II	Active
N/T Protein Control SL/L	10446079	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Horse Dander	10385650	FDA UDI	Class II	Active
IMMULITE®/IMMULITE®1000 Systems fPS Free PSA	10374043	FDA UDI	Class III	Active
IMMULITE®2000 Systems 3gAllergy™ nDer f 2	10360572	FDA UDI	Class II	Active
IMMULITE® Systems SBG Calibration Verification Material SHBG	10373703	FDA UDI	Class I	Active
IMMULITE® Systems FT3 Calibration Verification Material Free T3	10387963	FDA UDI	Class I	Active
Kaolin Suspension	10873859	FDA UDI	Class II	Active
BC von Willebrand Reagent	10874080	FDA UDI	Class II	Active
IMMULITE® 2000 Systems 3gAllergy™ Cultivated Wheat Grass	10385910	FDA UDI	Class II	Active
BC Thrombin Reagent	10446636	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Shrimp	10385745	FDA UDI	Class II	Active
DImension Vista® Retinol binding Protein	10445907	FDA UDI	Class I	Unknown
N Antiserum to Human Albumin	10714509	FDA UDI	Class II	Active
IMMULITE® 2000 Systems FSH	10381180	FDA UDI	Class I	Active
IMMULITE® Systems ACT CONTROL ACTH	10385382	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Cow Dander	10385651	FDA UDI	Class II	Active
Dade® CA System Buffer	10873440	FDA UDI	Class II	Active
IMMULITE® 2000 Systems CVG CMV IgG	10381309	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Australian Pine	10386104	FDA UDI	Class II	Active
IMMULITE 2000 rPru av 3 Specific Allergen	10471074	EUDAMEDFDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Carrot	10385797	FDA UDI	Class II	Active
N Antisera to Human IgM	10446301	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Wormwood	10386158	FDA UDI	Class II	Active
IMMULITE® Systems HPG CONTROL H.pylori IgG	10469596	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Privet	10386071	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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