Product description

Baby Boom Pregnancy Test Cassette: early pregnancy diagnosis

In vitro diagnostic medical device, intended for home use, single use.
This is a rapid test used to detect human chorionic gonadotropin (hCG) in urine samples for the early diagnosis of pregnancy in women.

APPLICATION:
Early diagnosis of pregnancy.

FEATURES:
Test accuracy: >99%,
Test sensitivity: hCG hormone concentration from 10 mlU/ml,
The test allows you to detect pregnancy as early as 7 days after conception.

PRINCIPLE OF OPERATION
The hCG test is a rapid, one-step immunochromatographic test. A membrane with an absorbent strip is placed over a glass fiber strip impregnated with a colloidal conjugate of gold particles and monoclonal antibodies against hCG. A second absorbent strip, located at the edge of the plate, absorbs excess liquid sample. A urine sample is applied to the chromatographic membrane plate. Upon contact with the membrane, the urine sample dissolves the lyophilized conjugate. In the reactive sample, the hCG antigen binds to antibodies in the colloidal solution. As the conjugate migrates along the membrane, the monoclonal anti-hCG antibodies in the test region (T) bind to the hCG-gold conjugate complex, forming a pink line (T). Adding each sample causes a pink line to appear in the control region (C). This line is formed by binding of polyclonal mouse IgG antibodies (located in the control region) to the sample-colloidal gold conjugate. The presence of a control line indicates that the test was performed correctly.

HOW TO USE:
A pregnancy test is performed using a clean urine sample.
Remove the test cassette from the foil pouch.
Using a pipette, collect a urine sample and place a few drops into the well on the cassette (2-3 drops, approximately 100 μl). Be careful not to overfill the absorbent pad.
Read the test result after 5 minutes. Depending on the hCG concentration in your urine, a positive result may appear after 40 seconds, but you should wait a full 5 minutes to confirm it. Do not read the result any later, as it may be inaccurate.
The test is intended for single use only. After reading the result, discard the test in a trash bin, treating it as a potential source of infection.

Precautions:
This product is intended for in vitro diagnostic use only. For external use only.
Before performing the test, please read the information leaflet carefully. Follow the instructions carefully.
Do not use the test after the expiry date printed on the foil pouch.
Each pregnancy test cassette is intended for single use only.
Do not use the test if the foil pouch is damaged.
After opening the foil pouch, perform the test immediately.
After reading the result, the test should be discarded. Treat the urine sample and test as a potential source of infection. Avoid skin contact.
Keep out of reach of children.

PACKAGE CONTENTS:
foil pouch containing a pregnancy test cassette: 1 pc.
pipette: 1 pc.
urine container: 1 pc.
instructions for use: 1 pc.

Responsible entity: PASO-TRADING SP. Z OO

CE 0123

This is a medical device. Use it according to the instructions for use or label.

Important information about the medical device:

• Medical device - has the CE marking.
• It has an EU declaration of conformity
• Includes user manual in Polish
• Includes label in Polish

Storage and transport of medical devices are in accordance with the conditions specified by the manufacturer.

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