Self Testing Instruction On Operation Of Urine-H Series Urinalysis Test Strip

INTENDED USE

Bioneovan Rapid Test for Detection of Norovirus antigen(Colloidal Gold) is an in vitro immunoassay for the qualitative determination of the detection of norovirus in human feces specimens in one step. As an auxiliary diagnosis of acute viral gastroenteritis, it quickly diagnoses the pathogen for disease, avoids the spread of hospitals or communities and reduces the need for unnecessary antibiotic therapy.

Product Name

Product Name: Urine-H Series, Urinalysis Test Strip (Dry Chemical Method) Model: Urine-H-11, Urine-H-10, Urine-H-8, Urine-H-3 and Urine-H-1

Precautions

1. Urine Sample: The first confirmed positive Occult Blood Ascorbic Acid ≤2.8mmol/L order shows no negative result.

1.1 Urine preservatives do not certainly prevent decomposition of ketone, bilirubin or urobilinogen. Therefore, collected urine should not be placed for too long (above 4h) for fear of compromised test results.

1.2 Contamination-caused bacterial growth might affect results of glucose, nitrite, pH and occult blood tests. Therefore, fresh urine samples must be collected for the tests.

2. Test Strip

2.1 DO NOTtouch test areas directly to prevent contamination.

2.2 Well seal the bottle cap after taking a test paper from the test paper bottle. 2.3 DO NOTremove desiccant in an unspent test paper bottle

Sample Requirement

Fresh urine must be collected in a dry and clean container. The storage period should be short (within 4 hours). Centrifugation for sufficient mixture of urine is unnecessary for the test.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world