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Procleix HIV-1/HCV/HBV Quality Control

GRIFOLS DIAGNOSTIC SOLUTIONS INC. · Model HIV-1/HCV/HBV Negative Control · UDI-DI 00850032683005

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

Description

Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.

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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.