Kraujospūdžio cholesterolio nustatymo kontrolinis skystis MultiSure GCTU

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Prekė: Kraujospūdžio cholesterolio nustatymo kontrolinis skystis MultiSure GCTU. Kategorija: Priedai.

• Gamintojas: Diather

MultiSure GCTU Cholesterol Control Solution is a liquid designed for verifying the correct operation of the MultiSure GCTU blood cholesterol testing system and compatible test strips.

Testing with the control solution allows confirmation that the measurement system is working correctly, and the results obtained are reliable.

The control test result should fall within the range of values provided on the test strip packaging. Obtaining a result within this range confirms the proper functioning of the device, test strips, and the accuracy of the test procedure.

When to perform the test with the control fluid:

• When you first use the system,
• After opening the new package of test strips,
• In case of suspicion of malfunction of the device or strips,
• When the measurement results are inconsistent or raise doubts,
• After dropping the device,
• When test strips were stored in the wrong conditions.

Test procedure:

1. Indicate the date of first opening on the control fluid package.
2. Check the expiry date – do not use after it has expired.
3. Insert the test strip into the device to start it.
4. Apply a drop of control fluid to a clean surface.
5. Apply the test strip to the droplet to start the measurement.

Storage and handling:

• The control fluid should be stored at 4°C – 30°C.
• Do not freeze or refrigerate.
• Do not use after the expiry date.
• Any unused control fluid should be discarded 90 days after first opening or after the expiry date.

Restrictions:

• Shake Cholesterol MultiSure Control Liquid well before use.
• DO NOT apply a second drop of control fluid to the reaction zone of the test strip.
• Do not smear the liquid with the tip of the bottle.
• After use, immediately close the bottle.
• Use only Cholesterol MultiSure Control Liquid.
• Always check the expiration date.
• DO NOT use expired control fluid.

Warnings and precautions:

• The product is intended for in vitro diagnostics only.
• Do not consume or inject.

Diather is certified ISO 13485:2016, issued by the accredited certification body IMQ, in the field of storage and distribution of IVD diagnostic tests.

During the certification audit and subsequent supervision audits, it was confirmed that the storage and distribution of products are carried out in accordance with the requirements of point 6.4 of ISO 13485:2016. The company cares about the working environment, controls the level of pollution and monitors key environmental parameters, such as temperature and humidity, both in the warehouse and during transport.

The company has implemented proceedings as part of the supervision of cleanliness and hygiene

Diather maintains medical device documentation adequately to the role of distributor during storage and distribution processes, which ensures the identification and traceability of the products distributed.

This is our significant competitive advantage – many sellers on platforms such as Allegro are so-called. “garage” sellers who compete only with a low price. Additionally, we have the “Consumer Discovery 2024” certificate, which confirms the high quality of our services and products. "

The product is CE marked with the number of the notified body (0197). The CE marking indicates that the product has been tested by the manufacturer and found to comply with EU health, safety and environmental requirements.

The product has an EU declaration of conformity - it meets the requirements of the European Union.

It is a medical device for self-control.

The product comes with a label and an instruction manual in Polish.

Manufacturer: APEX BIOTECHNOLOGY CORP.

Authorised representative: OBELIS S.A.

Advertising provider: DIATHER Petrusewicz Sp. K.

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

NOTE: due to the special storage conditions of the product (from 2°C to 8°C. ) in case of negative or very high temperatures outside, it is recommended to choose the form of delivery by courier instead of parcel locker.

Specifications