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Assay, Fetal Hemoglobin

FDA product code KQI · 4 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.7455
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1979-07-17 – 1988-04-21
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