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Control Material, Her-2/Neu, Immunohistochemistry

FDA product code NJW · 2 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.1860
Review panel
PA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2003-06-18 – 2022-08-15

Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.

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