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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device group a streptococcus nucleic acid amplification assay system
Regulation Description Streptococcus spp. serological reagents.
Definition An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
Product CodeOYZ
Regulation Number 866.3740
Device Class 1


Premarket Reviews
ManufacturerDecision
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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