510(k) K022504

IDI-STREP B ASSAY by Infectio Diagnostic, Inc. — Product Code NJR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 18, 2002
Date Received: July 29, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class: Class I
Regulation Number: 866.3740
Review Panel: MI
Submission Type

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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