In vitro diagnostic medical device CE 0123.
The Ferritin Rapid Test Cassette is a test for the qualitative detection of ferritin in human fingerstick blood for iron deficiency anemia.
For in vitro self-diagnostic use only.

Precautions
1. For in vitro self-diagnostic use only.
2. Do not eat, drink or smoke in the sample or kit handling area.
3. Store in a dry place at 2-30 ° C (36-86 ° F), avoiding areas with excessive humidity. If the sealed pouch is damaged or opened, please do not use the test.
4. This kit is intended for use as a preliminary test and repeated abnormal results should be discussed with a physician or specialist.
5. Strictly follow the times indicated.
6. Use the test only once. Do not disassemble or touch the test window on the holder.
7. The kit should not be frozen or used beyond the expiration date printed on the package.
8. Keep out of the reach of children.
9. Used test must be disposed of according to local regulations.

Method
1. Wash your hands with soap and rinse with clean warm water.
2. Bring the package to room temperature before opening it. Open the sealed package and take out the device.
3. Gently pull and discard the protective lancet cap.
4. Use the alcohol swab provided to clean the tip of the middle finger, where the puncture is located.
5. Press the lancet, from the side where the cap was removed, against the tip of the finger (the ring finger side is recommended). The tip retracts automatically and safely after use.
6. Keeping the hand pointing downwards, massage the puncture site to obtain a drop of blood.
7. Without pressing the bulb of the capillary dropper, put it in contact with the blood. The blood will migrate in the capillary dropper to the line indicated on the dropper.You can massage your finger again to get more blood if the line is not reached. As much as possible, try to avoid the formation of air bubbles.
8. Put the collected blood into the device sample well, squeezing the dropper bulb.
9. Wait until the blood has completely poured into the well. Unscrew the buffer bottle cap and add 1 drop of buffer to the device sample well.
10. Wait for the colored line (s) to appear. Read the results at 5 minutes.
Do not interpret the results after 10 minutes.

Interpretation of the results
NORMAL: Two lines appear, both the T (Test) and the C (Control) lines. This result indicates that the ferritin concentration in the blood is normal and that there is no potential iron deficiency.
ANOMALY: only one line appears, the control line (C). This result indicates that the ferritin concentration in the blood is too low. You should consult a doctor as there may be an iron deficiency.
NULL: the control line does not appear. The most likely reasons for control line failure are insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the kit immediately and contact your local distributor.

Limits
1. The Ferritin Rapid Test Cassette provides a qualitative analytical result only. An additional analytical method must be used to obtain a confirmatory result.
2. Technical or procedural errors may occur, as well as interference from other substances in the blood sample which could lead to erroneous results.
3. As with all diagnostic tests, all results are to be evaluated together with other clinical information available to the physician.
4. Other available clinical tests are required if questionable results are obtained.

storage
Store wrapped at room temperature or refrigerated (2-30 ° C). The test is stable until the expiration date printed on the sealed pouch or closed box. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

Format
Pack containing 1 piece.