510(k) K143312
K143312 is an FDA 510(k) premarket notification submitted by Great Basin Corporation for the device "Portrait GBS Assay". The FDA issued a decision of Substantially Equivalent on April 21, 2015. The device falls under product code NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test), a Class I device regulated under 21 CFR 866.3740.
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.