RegenLab BCT 3x Tubes
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
RegenKit® BCT is a sterile, closed system from Regen Lab SA for the preparation of autologous platelet-rich plasma. It is not a preparation with an active substance: it is a medical device for blood processing. Each pharmaceutical-grade glass tube contains sodium citrate as an anticoagulant and a thixotropic separating gel which, after a single 5-minute centrifugation, separates the platelet-rich plasma from the red cell fraction.
- Anticoagulant sodium citrate solution
- Separation thixotropic gel
- Centrifugation 1500 g · 5 min
- Contents 3 tubes
- Platelet recovery ≈ 80 %
Tube composition and technology
- Tube: evacuated pharmaceutical-grade glass, sterile and single-use.
- Anticoagulant: sodium citrate solution, of neutral pH and fully reversible.
- Thixotropic separating gel: during centrifugation it migrates and forms a physical barrier between the platelet-rich plasma and the erythrocytes, which allows the PRP to be recovered without carry-over of the red cell fraction.
- No added active substance: the product delivers no medicinal product or biological substance to the patient. All the material injected comes from the patient's own blood.
System performance according to the manufacturer's data:
| Platelet recovery | Approximately 80 % |
|---|---|
| Erythrocyte removal | Approximately 99.7 % |
| Granulocyte depletion | Approximately 96.5 % |
| Concentration factor | Adjustable between 1.6× and 5.9× |
Kit configurations
| 10 ml tube | Collection of 10 ml of blood per tube; 5 to 6 ml of PRP is obtained |
|---|---|
| 20 ml tube | Collection of 20 ml of blood per tube; 10 to 12 ml of PRP is obtained |
| RegenKit® BCT-1 | 1 tube plus accessories: safety butterfly needle, tube holder, transfer device, needles and 5 ml syringe |
| RegenKit® BCT-3 | 3 tubes, available in the 10 ml or 20 ml configuration |
Check on the pack received the tube volume and the accessories included with the particular reference.
Indications and treatment areas
Intended use: safe and rapid preparation of autologous platelet-rich plasma from the patient's own blood.
The PRP obtained is used in medical and regenerative aesthetic medicine procedures according to the judgement and qualification of the professional. The authorised indications for autologous PRP depend on the regulatory framework of each country; in Spain its preparation and application are subject to the legislation in force on the therapeutic use of platelet-rich plasma.
Preparation protocol
- Temperature: the tubes must reach room temperature before use.
- Collection: the patient's blood is collected directly into the evacuated tube, using the puncture system included or an equivalent. Mix gently with the anticoagulant.
- Centrifugation: 1500 g for 5 minutes, in a centrifuge with a fixed 45° angle rotor or a horizontal swing-out bucket.
- Centrifugation limits: below 1500 g the separation is insufficient; above 2200 g there is a risk of tube breakage.
- Recovery: after centrifugation, the separating gel lies between the PRP and the erythrocyte fraction. The PRP is drawn off with the transfer device.
- Window of use: the prepared PRP must be used within the following 4 hours.
Technical data
| Manufacturer | Regen Lab SA, Switzerland |
|---|---|
| Product type | Medical device for the preparation of autologous platelet-rich plasma. Without active substance |
| Tube material | Pharmaceutical-grade glass, evacuated |
| Anticoagulant | Sodium citrate solution |
| Separation system | Thixotropic separating gel |
| Presentation | Kit with 3 tubes (10 ml or 20 ml configuration according to reference) |
| Centrifugation | 1500 g for 5 minutes |
| Sterility | Supplied sterile; no prior sterilisation required |
| Classification | CE-marked medical device. Check the class and the notified body on the pack labelling |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- The pack contains: 3 RegenBCT tubes. Check on the labelling whether the reference received includes puncture and transfer accessories.
- Storage: between 5 °C and 30 °C.
- Before use: the tubes must reach room temperature.
- Do not use after the expiry date shown on the pack.
- Sterile single-use tubes. Do not reuse or re-sterilise. Do not use tubes that have lost their vacuum or whose packaging is damaged.
Warnings
Handling warnings: observe the centrifugal force indicated — exceeding 2200 g carries a risk of tube breakage inside the centrifuge. Always balance the centrifuge. Use the prepared PRP within the following 4 hours.
Traceability and biosafety: the product is used with the patient's own blood. Apply the relevant procedures for patient identification, handling of biological material and disposal of healthcare waste.
Regulatory framework: the obtaining and application of autologous platelet-rich plasma is subject to the national legislation in force and must be carried out by an authorised healthcare professional.
Always consult the instructions for use included in the pack before preparation.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official documentation of Regen Lab SA and on the device identification register (GUDID) entry for the RegenKit-BCT-3 reference. This data sheet does not replace the instructions for use accompanying the product.