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Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

FDA product code NQN · 13 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
2004-02-05 – 2013-11-22

Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

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