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 1 of 22

Device	Model / Reference	Registries	Class	Status
INNOVANCE Heparin LMW Control 1	10873929	FDA UDI	Class II	Active
Pathromtin SL	10873862	FDA UDI	Class II	Active
IMMULITE® Systems GAS Calibration Verification Material Gastrin	10387978	FDA UDI	Class I	Active
IMMULITE®/IMMULITE® 1000 Systems TSH Sample Diluent	10386996	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Basil	10385760	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Salmon	10385825	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Green Pepper	10385757	FDA UDI	Class II	Active
N Supplementary Reagent L	10446128	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Bahia Grass	10385912	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Tyrophagus putrescentiae	10385637	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Coconut	10385811	FDA UDI	Class II	Active
IMMULITE® 1000 System SD2 DIL HCG Sample Diluent	10385351	FDA UDI	Class II	Active
IMMULITE® 2000 Systems MD2 Multi-Diluent 2 Sample Diluent	10708432	FDA UDI	Class I	Active
IMMULITE® Systems PTH CONTROL Intact PTH	10385354	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Mouse Urine	10385673	FDA UDI	Class II	Active
IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent	10386994	FDA UDI	Class III	Active
IMMULITE®/IMMULITE® Systems 1000 Systems INS Insulin Sample Diluent	10387034	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Oat	10385856	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Peach	10385874	FDA UDI	Class II	Active
Protein C Reagent	10873871	FDA UDI	Class II	Active
Berichrom® Plasminogen	10446431	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Mouse Urine	10385657	FDA UDI	Class II	Active
ADVIA Centaur® HBcT2 Quality Control Kit	10376699	FDA UDI	Class II	Active
IMMULITE® 2000 Systems ACT ACTH	10381468	FDA UDI	Class II	Active
BFT II Analyzer	10458677	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems FSH Sample Diluent	10387026	FDA UDI	Class I	Active
INNOVANCE Apixaban Controls	10873674	FDA UDI	Class II	Active
Dade® Actin® FSL Activated PTT Reagent	10445713	FDA UDI	Class II	Active
Dade® PFA Trigger Solution	10445701	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems PHE Phenobarbital	10381512	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Weed Panel 3	10386174	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Duck Feathers	10385671	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Weed Panel 2	10386172	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Almond	10385714	FDA UDI	Class II	Active
Multifibren U	10873901	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Ox-Eye Daisy	10386164	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Baccharis halimifolia	10386159	FDA UDI	Class II	Active
Fibrinogen Calibrator Kit	10446148	FDA UDI	Class II	Active
Immulite® 3rd Gen. Psa Cvm	10713725	FDA UDI	Class I	Active
IMMULITE®2000 Systems 3gAllergy™ Turkey Feathers	10385674	FDA UDI	Class II	Active
IMMULITE® 2000 Systems SBG SHBG	10381198	FDA UDI	Class I	Active
IMMULITE® 2000 Systems VAL Valproic Acid	10381544	FDA UDI	Class II	Active
IMMULITE® 2000 Systems PAP	10380975	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Trout	10385708	FDA UDI	Class II	Active
IMMULITE®/IMMULITE® 1000 Systems T4 Sample Diluent	10387587	FDA UDI	Class II	Active
Dimension Vista hsCRP Flex reagent cartridge	10445898	FDA UDI	Class II	Active
IMMULITE®2000 Systems 3gAllergy™ Cocklebur	10386134	FDA UDI	Class II	Active
INNOVANCE Antithrombin	10709521	FDA UDI	Class II	Active
Dimension Vista® Flex® reagent cartridge LAMBDA	10465672	FDA UDI	Class II	Active
Dimension Vista® C-Reactive Protein Flex® reagent cartridge	10445893	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