SIEMENS HEALTHCARE DIAGNOSTICS INC.

Contract manufacturer · Newark, DE

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2013Product codes first listed, by year (tallest: 9)2026

FDA registration: 2517506 (openFDA record; or search FDA's registration database)
FEI number: 2517506
Registered for: FDA registration year 2026
Establishment types: Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator: SIEMENS HEALTHCARE DIAGNOSTICS INC. (FDA owner/operator no. 9096044)
Registered address: 500 GBC DR, PO Box 6101, Newark, DE 19714
Contract listings: 6 device listings, 9 product codes, first listed Jan 18, 2013
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
DIF	Drug Mixture Control Materials	Class I	Clinical toxicology	Contract manufacturing	Jan 18, 2013
DIS	Enzyme Immunoassay, Barbiturate	Class II	Clinical toxicology	Contract manufacturing	Jan 18, 2013
DKB	Calibrators, Drug Mixture	Class II	Clinical toxicology	Contract manufacturing	Jan 18, 2013
DLJ	Calibrators, Drug Specific	Class II	Clinical toxicology	Contract manufacturing	Jan 18, 2013
KLS	Enzyme Immunoassay, Theophylline	Class II	Clinical toxicology	Contract manufacturing	Jan 18, 2013
LCD	Enzyme Immunoassay, Gentamicin	Class II	Clinical toxicology	Contract manufacturing	Jan 18, 2013
LDO	Enzymatic Radiochemical Assay, Tobramycin	Class II	Clinical toxicology	Contract manufacturing	Jan 18, 2013
LEG	Enzyme Immunoassay, Valproic Acid	Class II	Clinical toxicology	Contract manufacturing	Jan 18, 2013
LEH	Radioimmunoassay, Vancomycin	Class II	Clinical toxicology	Contract manufacturing	Jan 18, 2013