Tasso · siet 2022 (FDA-510(k)-Freigabe, berichtet im September 2022) · 3× · tolest 18. Okt. 2026
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Momentum
Tasso+ is a single-use, sterile disposable blood lancet from Tasso, Inc. that, at the press of a button, collects capillary whole blood into a compatible collection tube. According to the manufacturer it is FDA 510(k)-cleared (Class II), CE-marked and licensed in Canada (Health Canada). It is intended for self-collection with shipment to an accredited laboratory; per the instructions for use it is not intended for diagnostic procedures (Research Use Only in the US).
Momentum-Verloop
20.07.18.10.
Features
| Compliance/Certification | FDA 510(k) Class II (blood lancet, 21 CFR 878.4850); CE marked; MHRA registered; Health Canada licence |
| Deployment Model | Single-use device; pre-made kits as procedure packs per Art. 22 MDR (EU) 2017/745 |
| Use Case Scope | Self-collection of capillary whole blood at home or point of care; sample shipped to accredited lab; per IFU not for diagnostic use |
| Integrations | Compatible with multiple standard collection tubes (e.g. BD Microtainer); bulk purchase for integration into sampling kits |
| License | Device: licensed under regulation (FDA 510(k) Class II, Health Canada); kits in US Research Use Only |
| Platform | Handheld single-use blood lancet with adhesive patch, compatible with standard collection tubes |
