Solana Group A Strep Assay

Trade name

Solana

Generic name

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Model / Ref / Catalog

Group A Strep Assay, M301

Primary DI / UDI-DI

30014613336082

FDA product code

PGX

GMDN term

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Device class

Class II

Regulation number

866.2680

GUDID distribution status

In Commercial Distribution

Category: Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Other devices filed under FDA product code PGX (Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system).

• Simplexa™ Group A Strep Positive Control Pack MOL2860 by DiaSorin Molecular LLC
• ID NOW Strep A 2 Control Swab Kit 734-080 by Alere Scarborough, Inc.
• Accula Strep A Test by MESA BIOTECH, INC.
• GenePOC Strep A by Genepoc, Inc.
• LIAISON NES Group A Strep by DiaSorin Molecular LLC
• Xpert Xpress Strep A by CEPHEID
• LIAT STREP A ASSAY by Iquum, Inc.
• ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit by Luminex Corporation
• Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack by Focus Diagnostics, Inc.

• QuickVue 20125 Open recall

  Class I

  CE/IVDD FDA 510(k) K011097 Active Cleared 8 May 2001 +1authorizations

• Sofia 20253

  Class I

  FDA 510(k) K123793 Active Cleared 17 Jun 2013 GUDID on market

• MicroVue C1-Inhibitor

  Class II

  CE/IVDD GUDID on market

• Sofia 20298

  Class II

  GUDID on market

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