# Diagnostics Manufacturing Services Archives

Source: https://lso-inc.com/division/diagnostics-manufacturing-services/

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FDA-Registered

Manufacturing Facility

ISO 13485

Certified Quality System

12 Cleanrooms

Class 5–8

125,000+ Sq Ft

Regulated Manufacturing

3 Facilities

CA | NH | Costa Rica

ISO 17025

Accredited Packaging Lab

## Diagnostics Manufacturing & Packaging Services

Our Diagnostic Services help OEMs bring microfluidic cartridges, point-of-care platforms, and automated consumables to market with confidence. We focus on precise reagent delivery, material compatibility, and long-term stability—delivered through our integrated manufacturing, packaging, and sterile barrier capabilities as a division of Life Science Outsourcing, Inc.

years of package testing expertise

devices validated across EtO, radiation, and steam

regulatory submissions supported (FDA, EU MDR)

ISO 11135 / 11137 / 17665 compliant studies

Sterilization Validation Services (SVS), a division of Life Science Outsourcing, Inc., is responsible for the sterilization and validation of single use and reusable products and related documentation. SVS promises to assist you in your choice and evaluation of the ideal sterilization methodology best suited to your product.

## Related Diagnostics Manufacturing Services

Specialized diagnostics device and consumables manufacturing capabilities.

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### Diagnostics Assembly & Kitting

Cleanroom assembly and kitting purpose-built for IVD and point-of-care diagnostics.

See assembly & kitting](https://lso-inc.com/diagnostics-assembly-kitting/)

### Consumables Manufacturing

High-volume precision filling and packaging of diagnostic consumables and reagents.

See consumables manufacturing](https://lso-inc.com/diagnostics-consumables-manufacturing/)

### Diagnostics Design For Manufacturing

DFM engineering to scale diagnostic devices from prototype to commercial volume.

See design for manufacturing](https://lso-inc.com/diagnostics-design/)

### In-Vitro Diagnostics

IVD-specific expertise: cleanroom assembly, validated packaging, regulatory documentation.

See in-vitro diagnostics](https://lso-inc.com/in-vitro-diagnostics/)

### POC Diagnostics Blister Packaging

Custom blister and pouch packaging for point-of-care diagnostic devices.

See POC packaging](https://lso-inc.com/services/microfluidics/point-of-care-diagnostics-packaging-blister-packs/)

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