Certificate of Analysis - Visual Control of Container,Test Strips and Label - Functional Test with Test Urine

Sep 2, 2026

Upload by Ivy

This document outlines the Certificate of Analysis for a diagnostic product, focusing on quality control measures for diagnostic tests. It details visual inspection parameters for the container, test strips, and labels, ensuring they meet specified requirements. The analysis also includes residual moisture testing for both the stopper and desiccant pack, with results compared against established upper and lower limits. A functional test using test urine is performed to confirm that the test strips perform according to the criteria outlined in document IRL-UAQC-PCD-0005. The document includes commission and customer details, reference numbers, expiration dates, and storage conditions (30℃ 2℃-). Signatures from release and verification personnel, along with their respective dates, are present, signifying the completion of quality assurance checks.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages2

Reading Time5 min

AccessFree to download

Certificate of Analysis

Quality Control Diagnostics

Visual control of container,test strips,label and residual moisture

:Visual Control of container,test strips and label

:Residual Moisture of Stopper

:Residual Moisture of Desiccant Pack

Functional Test with Test Urine

:Functional Testing with Test Urine

FAQs

What are the main quality control parameters tested in this document?

The document details visual control of the container, test strips, and labels, along with residual moisture tests for the stopper and desiccant pack. It also includes a functional test with test urine.

What are the specified storage conditions for the diagnostic product?

The specified storage condition is 30℃ ± 2℃.

What is the purpose of the functional test with test urine?

The functional test with test urine is performed to ensure that the test strips meet the criteria specified in document IRL-UAQC-PCD-0005.

Sep 2, 2026

Upload by Ivy