Class Class II

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K250249)

K250249 2025-10-10 Traditional
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Description

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System by Gold Standard Diagnostics, LLC, an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250249
Clearance Date2025-10-10
Clearance TypeTraditional
Product CodeGMQ
Regulation Number866.3820

Categories

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