
Beckman Instruments, Inc.
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IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT is an FDA 510(k)-cleared medical device (K965033) manufactured by Beckman Instruments, Inc.. This device is classified under the Immunology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 20, 1997. Regulation: 8.