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Parsortix® PC1 system

ANGLE PLC · Model MBC-IVD-01-010-US · UDI-DI 05056364200094

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

Description

Parsortix® PC1 Metastatic Breast Cancer Kit, US containing 10XParsortix PC1 GEN3P6.5IVD Cell Separation Cassettes, 1XParsortix PC1 GEN3C Cleaning Cassettes, 10XSample label sets, 1Xpackage insert (per kit) containing instructions for use and expected performance data for the Parsortix PC1 instrument, when used in conjunction with the Parsortix PC1 MBC-01 Metastatic Breast Cancer 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.