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ORTHO-CLINICAL DIAGNOSTICS GMBH

ORTHO-CLINICAL DIAGNOSTICS GMBH is a federal contractor, registered under UEI GM5SLSX6DLH5 and CAGE code DB116. It has been awarded $6,011,321 in federal contracts. Primary work spans In-Vitro Diagnostic Substance Manufacturing, Medical Laboratories, and Electromedical and Electrotherapeutic Apparatus Manufacturing. Top awarding agencies include Department Of Defense and Other agencies (2 agencies, <0.5% each).

Contact Information

Registration and classification details

Registration

UEI Code

GM5SLSX6DLH5

CAGE Code

DB116

Entity Structure

International Organization

Established

N/A

Business Classifications

For Profit Organization

NAICS Codes

325413In-Vitro Diagnostic Substance Manufacturing(Primary)

Federal Contracting Overview

Award totals, agency breakdown, NAICS distribution, and geographic footprint.

AI Capability Profile

Ortho-Clinical Diagnostics GmbH specializes in the manufacture and support of in-vitro diagnostic substances and precision laboratory instrumentation for military and veteran healthcare systems. Their core capabilities center on producing consumables compatible with Ortho Vision analyzers, deliverin...

Ortho-Clinical Diagnostics GmbH specializes in the manufacture and support of in-vitro diagnostic substances and precision laboratory instrumentation for military and veteran healthcare systems. Their core capabilities center on producing consumables compatible with Ortho Vision analyzers, delivering full-service maintenance for automated clinical chemistry systems such as the VITROS 5600, and supplying reagents integrated with power and environmental safeguards like UPS systems. The contractor demonstrates deep technical expertise in diagnostic assay formulation, analyzer calibration, and end-to-end supply chain logistics for decentralized testing environments, ensuring uninterrupted operation in field and hospital lab settings. Their specialization in FDA-regulated diagnostic reagents and FDA-cleared instrument compatibility distinguishes them as a trusted provider for mission-critical clinical testing in austere or high-throughput environments. The contractor maintains a consistent relationship with the Department of Defense, supplying diagnostic consumables and full-service analyzer support for deployed medical units and military treatment facilities. They also serve the Department of Veterans Affairs with precision equipment maintenance, indicating a focus on sustaining legacy and modern diagnostic platforms within veteran healthcare networks. Their engagement patterns suggest long-term, repeat-order partnerships built on reliability, regulatory compliance, and technical integration with government-owned instrumentation. Their primary industry focus is in-vitro diagnostic substance manufacturing, with secondary expertise in analytical laboratory instrument manufacturing and medical instrument servicing. This positions them as a niche provider in the defense and veterans’ healthcare diagnostics ecosystem, bridging reagent supply, instrument maintenance, and system integration under a single vendor model. Ortho-Clinical Diagnostics GmbH operates as a foreign entity with headquarters in Cologne, Germany, and holds no U.S. government certifications. Their market presence is defined by direct support to U.S. federal healthcare infrastructure through compliant, export-controlled diagnostic products and service agreements, serving as a critical non-domestic supplier in the U.S. government’s medical diagnostics supply chain.

Key Performance Metrics

Awards Count

71

All time

Active

2

Currently performing

Completed

69

Past period of performance

Total Awards

All time

Contracts

Prime · all time

Subcontracts

Sub · all time

Grants

Prime · all time

Subgrants

Sub · all time

Award Analytics & Distribution

Awards by Agency
Department Of Defense$6.0M99.4%
Other agencies (2 agencies, <0.5% each)$34.0K0.6%
Awards by Agency Over Time
Awards by Place of Performance

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