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LifeScale AST

Affinity Biosensors, LLC · Model 3010-0000 · UDI-DI 00860012092109

SANLON
1
510(k) clearances
2
Adverse events
0
Recalls
7
Facilities

Description

LifeScale AST is a semi-automated instrument system for antimicrobial susceptibility testing (AST) directly from positive blood cultures for which the Gram stain shows gram-negative bacilli.

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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.