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Microscope, Automated, Image Analysis, Operator Intervention

FDA product code NOT · 12 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.1860
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2003-12-23 – 2026-07-02

Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.

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