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Alpha-1-Antitrypsin Kit, Qualitative Phenotype

FDA product code OBZ · 2 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5130
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2007-06-11 – 2022-10-13

The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.

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