Instructions for Use
Intended Use:
To remove small sections of dermal tissue, including deep layers (epidermis, dermis, and superficial fat) to minimize damage to surrounding tissue, and to fix and store the tissue in a collection vial for downstream processing in skin biopsy test procedures performed by CND Life Sciences.
Device Description:
CND Life Sciences’ skin biopsy collection kit is a combination product convenience kit containing a skin biopsy punch pack and specimen transport vial(s). The skin biopsy punch pack contained within the collection kit is provided sterile, with the method of sterilization being EtO (Ethylene oxide). It is intended for use in a single procedure only. The provided specimen transport vial is a polypropylene tube containing 5mL of Zamboni fixative, a yellow pungent liquid, suitable for fixing small specimens for a variety of test procedures performed by CND Life Sciences. The instructions for this device are not meant to define or suggest any medical or surgical technique. The performing practitioner is responsible for the appropriate procedure and technique to be used with this device.
Contraindications:
Do not use the Skin Biopsy Collection Kit under the following conditions:
- If the expiration date has passed
- If the enclosed skin biopsy punch pack or its components are broken/damaged
- If the enclosed transport vial does not contain sufficient fixative
- There are other signs of deterioration
PRECAUTIONS:
- Intended for single patient/participant use only. Do NOT reuse
- The device may only be used by a licensed clinician
- Caution should be exercised for patients on anti-platelet or anti-coagulant therapies
- Do not collect specimens on compromised skin or open wounds
- Intended for use in CND Life Sciences skin biopsy collection procedures only
- Medical professionals and assistants should always wear appropriate personal protective equipment (PPE) when performing a skin biopsy procedure
- Dispose of all opened instruments whether used or unused
- Do not substitute fixative
WARNINGS:
- Zamboni fixative contains paraformaldehyde, which is suspected of causing cancer. It may cause an allergic skin reaction, causes serious eye damage and skin irritation, and may be harmful if swallowed, inhaled, or absorbed through the skin. Refer to the Material Safety Data Sheet for more information
- Sterility of the enclosed skin biopsy punch pack cannot be guaranteed if the package is broken/damaged prior to use
- Extra care should be taken while handling the device to keep it from coming into contact with contamination
- The tip of the 3mm punch tool is very sharp and should be handled with care
- Minimal bleeding may be noted after the procedure
ADVERSE EVENTS:
- Excessive bleeding at biopsy site
- Wound infection at biopsy site
- Surrounding skin damage at biopsy site
- Soreness or tenderness at biopsy site
- Scarring at biopsy site
- Vagal reflex
Materials:

Directions for Use:
Specimens should be considered potentially infectious and handled accordingly.
- Cleanse the biopsy collection site with the provided alcohol or iodine prep pad.
- At the collection site, use the provided 3mm punch biopsy tool, and apply gentle pressure while twisting the tool until the metal head is fully inserted into the skin.
- Remove the punch tool and use the provided forceps and scissors to release the specimen from the underlying tissue and place the specimen directly into a unique transport vial containing 5mL fixative.
- If the biopsy specimen remains in the punch biopsy tool, additionally use the provided metal probe to gently push the specimen out of the 3mm punch tool directly into the vial. The biopsy should be submerged and free-floating in the fixative.
- Use the provided gauze and bandage to stop bleeding and to cover the biopsy site.
- Repeat steps for each biopsy collected based on the test specification, not to exceed the number of provided transport vials.
- Store and transport collected specimens in transport vials in accordance with test specifications.
Storage & Handling:
Do not remove kit components until immediately before use.
Shelf Life:
Expiration is determined by individual combined product components.
Disposal:
Dispose of device as biohazardous medical waste in accordance with facility or institutional guidelines/procedures.
For Further Information:
Please visit cndlifesciences.com
Health care facilities may request a paper copy of the Instructions for Use at any time. Please email us at support@cndlifesciences to request a copy.


Manufacturer:
CND Life Sciences
9165 E Del Camino Dr, Suite 101
Scottsdale, AZ 85258-4381
cndlifesciences.com
CND-IFU-001, Rev 01