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Device |
nucleic acid amplification assay system, group b streptococcus, direct specimen test |
Definition |
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status. |
Product Code | NJR |
Regulation Number |
866.3740
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Device Class |
1
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