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St2 Assay

FDA product code OYG · 1 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1117
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-12-09 – 2011-12-09

Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.

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