EDTA K2 K3 Anticoagulant Blood Collection Tube Purple Top For Whole Blood Testing

The EDTA K2 K3 blood collection tube is engineered to prevent clotting by chelating calcium ions ensuring the blood remains in a stable anticoagulated state for comprehensive cell counting Our refined spraying process and strictly controlled manufacturing standards prevent external pollutants from affecting the sample integrity This optimized approach guarantees consistent and reliable clinical detection data for routine hematology and blood morphology examinations.

Dual Anticoagulant Options

Featuring both K2 EDTA dipotassium and K3 EDTA tripotassium configurations this tube series is engineered for superior blood cell preservation and comprehensive coagulation prevention Our high purity EDTA salts ensure maximum cell morphology stability for precise hematological evaluation.

Wide Clinical Applications

Primary utility focuses on intensive hematology testing including CBC Complete Blood Count blood grouping and cross matching procedures It serves as an essential diagnostic tool for clinical laboratories hospital hematology departments and specialized medical diagnostic centers requiring high precision sample integrity.

Premium Material and Design

Manufactured with high quality PET plastic or specialized glass to accommodate different laboratory safety standards and centrifugal speeds The high transparency tube body is optimized for clear sample observation efficient inspection and secure long term specimen storage.

1. EU CE IVD Compliance Declaration

   Our single-use blood collection tubes comply with the EU In Vitro Diagnostic Medical Devices Regulation (EU 2017/746, IVDR), with a self-declaration of conformity issued under Class A classification. The full product range (Plain tube, EDTA, Sodium Citrate, Heparin, Clot Activator tubes, etc.) meets EN ISO 20417, EN ISO 15223-1 and other harmonized standards, ensuring legal access to the EU market.

2. ISO 9001:2015 Certified Quality Management System

   Our factory has passed ISO 9001:2015 (GB/T 19001-2016) certification for quality management systems. This international standard ensures consistent production quality, standardized processes and continuous improvement, covering the manufacturing of Class II medical devices including single-use vacuum blood collection tubes.

3. ISO 13485:2016 Medical Device QMS Certified

   Our production system complies with ISO 13485:2016 (GB/T 42061-2022), the dedicated quality management standard for medical devices. This certification ensures full control over risk management, traceability and regulatory compliance for our single-use blood collection tubes.