Kit Description
The Habibti Test kit includes the device and all supplies necessary to collect a blood sample. The device is an FDA 510(k)-cleared blood lancet. It is a sterile, disposable blood lancing device. When collecting a sample, the device is held onto the skin by a mild adhesive. A sterile lancet punctures the skin with a press of the button. Simultaneously, this creates a slight vacuum that helps capillary blood flow under gravity into a compatible tube. After a predefined time period, or when the tube is full, the device is peeled off the skin. The tube is removed and capped for transport. The lancet is single-use and automatically retracts into the device in a safe position after use.
Kit Contents
Step 1
• Blood Lancing Device (FDA 510(k) - cleared)
• Compatible Tube, refer to manufacturer’s labeling
• Heat Pack
• Bandage
• Alcohol Swab
• Return Bag with Absorbent Pad
• Instructions for Use
Intended Purpose
Allows self-collection of microliter capillary whole blood samples in a compatible sample collection reservoir that is shipped to an accredited laboratory for analysis.
Precautions
• For use only on a single patient. Discard the entire device after use.
• Do not use after expiration date.
• Single use only.
• Keep out of reach of children.
• Not for use on infant heels.
• Do not resterilize.
• For external use only.
• Do not use if device packaging has been opened or damaged.
• Use while seated as fainting may occur with any blood sampling procedure.
• Refer to manufacturer’s instructions for individual components.
• Use personal protective equipment when handling biohazardous materials.
• Minor bruising, residual marks, or scarring may occur at the sample collection site. Note: The occurrence and severity of these events depend on patient physiological characteristics and chosen anatomic site.
• Multiple collections from the same anatomic location may increase the risk of residual marks or scarring and may impact the healing process.
• Do not perform collections on an area that shows evidence of skin issues such as infection, inflammation, extensive scarring, or broken skin.
• Patients taking blood thinners may experience prolonged bleeding.