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HER2/ER/PR IHControls®

Boston Cell Standards Inc · Model Level M · UDI-DI 00850045519018

NJW Prescription
1
510(k) clearances
2
Adverse events
0
Recalls
2
Facilities

Description

HER2/ER/PR IHControls® - Level M are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.

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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.