EDTA K2 K3 Purple Cap Anticoagulant Blood Tube For Hematology Analysis

EDTA anticoagulant is added into this type of blood collection tube, and EDTA salt combines with calcium ions in the blood to form a chelate, thereby preventing blood coagulation. In addition, through the control of the production environment and the innovation of the additive process, the influence of process pollution on the test results can be effectively eliminated.

Anticoagulant Type:

K2 EDTA (dipotassium ethylenediaminetetraacetic acid)

K3 EDTA (tripotassium ethylenediaminetetraacetic acid)

Both used for blood cell preservation and preventing coagulation

Applications:

Mainly used in hematology tests (e.g., CBC – Complete Blood Count)

Suitable for clinical laboratories, hospitals, and diagnostic centers

Tube Material:

High-quality PET plastic or glass

Transparent body for easy observation

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.