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NJR — Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Class I

FDA Device Classification

Classification Details

Product Code
NJR
Device Class
Class I
Regulation Number
866.3740
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

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