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HARDY DIAGNOSTICS · Model DR900A · UDI-DI 00816576021840

MYI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

MRSA-Screen consists of latex reagent sensitized with a monoclonal antibody against penici|lin—binding protein 2'(2a). or PBP2' (PBP2a), together with control latex and 2'extraction reagents to rapidly extract PBP2' from the bacterial cell membranes of MRSA. Extracts are prepared by boiling a suspension of S. aureus cells under alkaline conditions, followed by neutralization and a centrifugation step. The supernatant is subsequently mixed with the latex reagents on a test card and visible clumping or agglutination within three minutes with the sensitized latex but not the control latex confirms the presence of MRSA. MATERIALS SUPPLIED Sensitized Test Latex - (dropper bottle with pink cap) Latex particles are sensitized with a monoclonal antibody against PBP2'. Control Latex - (dropper bottle with a blue cap) Latex particles are sensitized with a monoclonal antibody of the same IgG subclass but against a human protein showing no reactivity with proteins of Staphylococcus aureus . Extraction Reagent 1 - (green cap) 0.1 mol/L NaOH Extraction Reagent 2 - (yellow cap) 0.5 mol/L KH 2 PO 4 Test Cards Mixing Sticks Package Insert

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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.