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Xpert BCR-ABL IS Panel C130

Mmqci · Model v.00 · UDI-DI 00852720008060

QIG
0
510(k) clearances
1
Adverse events
0
Recalls
1
Facilities

Description

Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.