WHO
REGULATORY UPDATE
WHO Prequalification of cobas® MTB‑RIF/INH
Published: 6/19/2026Detected: 4/30/2026
Summary preview
Prequalification of the cobas® MTB‑RIF/INH assay confirms WHO alignment with international quality, safety, and performance expectations for IVDs under the WHO Prequalification programme.
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manufacturing
quality
clinical
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labeling
#WHO prequalification
#in vitro diagnostics (IVD)
#tuberculosis
#rifampicin resistance
#isoniazid resistance
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