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Parsortix® PC1 system

ANGLE PLC · Model ICT-IVD-01-010.B2-US · UDI-DI 05056364200117

QSA Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
1
Facilities

Description

Parsortix® PC1 Instrument Control Test Kit, US, Box 2 (Ambient) containing 10X12mL sample tubes, 10XParsortix PC1 GEN3P6.5IVD Cell Separation Cassettes, 10XICT label sets, 1Xpackage insert (per kit) containing instructions for use for the Parsortix PC1 ICT-01 Instrument Control Test Kit.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.