Product Code: PGX

Products Classified as PGX

3564

Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

Streptococcus Spp. Nucleic Acid-based Assay.

Total Product Life Cycle (TPLC) Devices

3564

Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

Streptococcus Spp. Nucleic Acid-based Assay.

Pre-market Notifications for PGX

K183366	GenePOC Strep A	GenePOC Inc.
K173653	Alere I Strep A 2, Alere I Instrument, Alere I Strep A 2 Control Swab Kit	Alere Scarborough, Inc.
K173398	Xpert Xpress Strep A	Cepheid
K172402	ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit	Luminex Corporation
K172126	Xpert Xpress Strep A	Cepheid
K162274	Solana Strep Complete Assay	Quidel Corporation
K150868	Solana GAS Assay, Solana Instrument	QUIDEL CORPORATION
K143651	Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack	FOCUS DIAGNOSTICS, INC.
K141757	ALERE I STREP A	ALERE SCARBOROUGH, INC
K141338	LIAT STREP A ASSAY	IQUUM INC
K141173	AMPLIVUE GAS ASSAY	QUIDEL CORPORATION

Global Unique Device Identification Database

• 00875197005646: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
• 00875197005622: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
• 07613336156544: Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system
• 07613336129692: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
• 07332940006372: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
• 07332940002503: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
• 30014613336136: Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system
• 30014613336082: Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system
• 30014613312123: Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system
• 30014613311126: Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system
• 20816101025576: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
• 20816101025569: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
• 00628055344179: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
• 00840487101469: Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system
• 00840733102325: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Maude Adverse Events

ID NOW STREP A 2

ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

2019-10-18