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510(k) K143312

Portrait GBS Assay by Great Basin Corporation — Product Code NJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2015
Date Received
November 18, 2014
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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