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Dengue Virus Antigen Assay

FDA product code QCU · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3945
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-08-27 – 2018-08-27

Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection

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