Description

Testosterone Test Kit, 25 Tests/Box

Product Description

Testosterone Test Kit (25 tests per box) is professional in vitro diagnostic reagent adopting mature immunochromatography technology and produced following global IVD standards. It realizes stable and precise testosterone detection for routine clinical examination, exclusively operated by certified medical practitioners. Widely applied in hospitals, clinics, independent diagnostic labs, physical examination centers and medical research institutes globally. The product passes abundant lab verification and clinical trials to guarantee detection accuracy, specimen safety and stable batch consistency; all finished goods implement strict factory QC to satisfy international quality and regulatory rules.

Core Features

• Professional IVD reagent for in-vitro testosterone detection
• Mature immunochromatography technique for stable test results
• Complete safety design to protect operators and biological samples
• Stable detecting performance under varied clinical lab surroundings
• Full certification complying with mainstream international medical standards
• Simplified operating steps for licensed clinical workers

Detailed Technical Specifications

表格

Clinical Application

Intended Use

For qualitative & quantitative in-vitro determination of testosterone concentration in human serum, plasma or whole blood by qualified medical staff, serving as auxiliary diagnostic index of endocrinopathy, male reproductive dysfunction and related metabolic disorders.

• Male endocrine function screening
• Andrological & reproductive disease auxiliary diagnosis
• Endocrine disorder clinical inspection
• General health physical checkup
• Relevant medical scientific research

Product Advantages

• High detection precision supporting reliable clinical auxiliary diagnosis
• Excellent batch-to-batch consistency of test outcomes
• Easy operation cutting laboratory testing time cost
• Complete international certifications facilitating global registration and export
• Ambient temperature storage with long valid period
• Full-set after-sales technical & clinical consulting service

Regulatory Certifications

• FDA Registration: Permitted for sales and clinical application within USA market
• CE(MDR): Compliant with EU medical device regulation for free circulation across European Union
• ISO13485: Manufactured under certified quality management system
• ISO10993: In line with medical device biocompatibility evaluation criteria
• ISO11135: EO sterilization executed per international sterilization specification

Operation Specification

• Operators: Only professionally trained medical personnel follow enclosed instruction manual for testing
• Safety: Strictly implement safety protocols written in product manual
• Storage Management: Keep away from high temperature and damp to preserve reagent validity
• Testing Rule: Conduct detection complying with hospital SOP and local medical regulatory requirements
• Record: Complete usage log for product traceability and compliance inspection

Quality Control

Each production lot undergoes finished-product inspection covering detecting accuracy, reagent stability, operation safety, batch uniformity and package intactness to secure steady clinical performance.

After-sales Support

• 24-hour online technical troubleshooting service
• Remote or on-site operating training for lab technicians
• Preventive storage & maintenance guidance
• Original matching consumables supply
• Global registration document & regulatory consulting
• Professional clinical application guidance