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RSV Positive Control

MERIDIAN BIOSCIENCE, INC. · Model 751110 · UDI-DI 00840733103476

MJX Prescription
7
510(k) clearances
2
Adverse events
1
Recalls
14
Facilities

Description

RSV Positive Control is an external control reagent to be used with TRU RSV Test Kits as part of a routine quality control program.

Recalls

DateFirmReason
2016-06-22Ortho-Clinical DiagnosticsThe signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Contr

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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.