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Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

FDA product code NJR · 17 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.3740
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2002-11-18 – 2023-09-27

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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