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Flow Cytometric Reagents And Accessories.

FDA product code OYE · 6 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.5220
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2013-07-26 – 2023-11-22

To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

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