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Multichem ID-HIV p24

TECHNO-PATH MANUFACTURING LIMITED · Model SR111U · UDI-DI 05391523442121

QCH
1
510(k) clearances
0
Adverse events
0
Recalls
15
Facilities

Description

Multichem ID-HIVp24 is intended for use as a qualitative quality control to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by the heterogeneous immunoassay systems listed in the Instructions for Use. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

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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.