Description

PRL Test Kit, 25 Tests Per Box

Product Description

PRL Test Kit (25 tests/box) is a professional in-vitro diagnostic medical reagent for clinical medical detection. Developed with mature immunochromatography technology and produced complying with global medical device specifications, the kit delivers stable and accurate detection results for routine clinical testing.

Designed for professional clinical scenarios, it balances reliable detection performance and simple operating steps for certified medical practitioners. Widely applicable to hospitals, outpatient clinics, independent diagnostic labs and medical inspection institutions globally, the product passes repeated laboratory verification and clinical trials to guarantee detection precision, specimen safety and batch consistency. All finished products go through strict factory QC inspection to satisfy international quality and regulatory criteria.

Core Features & Specs

• Professional IVD reagent for clinical prolactin testing
• Mature immunochromatography technology for stable test results
• Strict safety design protecting operators and clinical specimens
• Stable detection performance amid various clinical testing conditions
• Certified to meet mainstream international medical device standards
• Simplified operation for licensed medical workers

Detailed Technical Parameters

表格

Clinical Application

Intended Purpose

For quantitative/qualitative in-vitro detection of Prolactin (PRL) concentration in human serum, plasma or whole blood by qualified medical staff, used as auxiliary index for endocrine and reproductive system disease screening.

• Endocrine function screening
• Gynecology & obstetrics auxiliary diagnosis
• Reproductive disorder clinical testing
• Physical examination screening service
• Related clinical research

Product Advantages

• Precise detection data for reliable clinical auxiliary diagnosis
• Stable batch-to-batch consistency of test outcomes
• Easy-to-follow operating steps to save lab testing time
• Complete global certification for cross-border registration & sales
• Long shelf life with convenient normal-temperature storage
• Full after-sales technical and clinical support

Regulatory Certifications

• FDA Registered: Approved for US market clinical application and sales
• CE (MDR): Compliant with EU medical device regulation for EU circulation
• ISO13485: Production under certified quality management system
• ISO10993: Biocompatibility passed medical device biological evaluation standard
• ISO11135: EO sterilization following international sterilization norms

Operation Specification

• Operator: Only professionally trained medical operators follow manual to perform tests
• Safety Rule: Strictly abide by product manual safety operation specifications
• Maintenance: Store properly, avoid high temperature/humidity to keep reagent validity
• QC Management: Execute testing per hospital lab SOP and relevant medical regulations
• Document: Record test usage and batch information for traceability

Quality Control

Every kit is subject to finished-product inspection covering detection accuracy, reagent stability, operation safety, batch uniformity and packaging integrity before delivery to ensure consistent clinical performance.

After-sale Service

• Round-the-clock online technical troubleshooting support
• On-site or remote operation training for laboratory staff
• Regular preventive maintenance guidance
• Original matching accessory supply
• Global registration document & regulation consulting
• Professional clinical application guidance