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Device
test, hiv detection
Review Panel
Immunology
Product Code
MZF
Submission Type
PMA
Device Class
3
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Recognized Consensus Standard
CLSI MM06-A2
Quantitative Molecular Methods for Infectious Diseeases; Approved Guideline - Second Edition
Third Party Review
Not Third Party Eligible
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