Looking to start a blood collection tube manufacturing unit in the USA? Operon Strategist provides turnkey support for facility setup, FDA 510(k) clearance, ISO 13485 QMS, and cleanroom design. With market demand rising for diagnostic consumables, our expert consultants help startups and manufacturers enter the $10B+ global market confidently and compliantly.

Blood Collection Tube Manufacturing:
A Complete Guide for Medical Device Startups Operon Strategist offers comprehensive consulting services for establishing a blood collection tube manufacturing facility, a growing segment driven by global demand for diagnostic healthcare solutions. We provide step-by-step guidance on compliance, facility design, quality control, and FDA documentation.

Overview of Blood Collection Tubes:
Blood collection tubes are sterile, evacuated containers used in diagnostic laboratories. Made from PET or glass, they contain additives like EDTA, Heparin, Citrate, or Fluoride to support various testing applications.

Common Types We Support:
EDTA Tubes – Hematology
Citrate Tubes – Coagulation
Heparin Tubes – Plasma separation
Serum Tubes – With or without gel
Fluoride Tubes – Glucose testing
Each type is color-coded and must comply with strict manufacturing and labeling standards.

End-to-End Services Offered:
Facility layout and ISO cleanroom design
Equipment selection: molding, filling, sealing, labeling
Raw material sourcing and additive setup
FDA 510(k) submission documentation and strategy
Design History File (DHF) and Device Master Record (DMR) preparation
Quality Management System (21 CFR Part 820 & ISO 13485:2016) implementation


Sterilization protocols: ETO and Gamma Radiation
Biocompatibility, vacuum, sterility, and shelf-life testing setup
UDI labeling and full traceability solutions

Market Opportunity:
The global blood collection market is projected to surpass $10 billion by 2030, with the USA contributing a major share. Key drivers include:
Increased diagnostic testing
Government healthcare programs
Rising chronic illness rates
Aging population and wellness awareness

A compliant and strategically positioned facility can serve both domestic and global healthcare markets.

Contact Us:
Operon Strategist – Regulatory & Technical Consulting
Website: https://operonstrategist.com
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