Product Code: OZE

Products Classified as OZE

3548

Influenza A And Influenza B Multiplex Nucleic Acid Assay

Respiratory Viral Panel Multiplex Nucleic Acid Assay.

Total Product Life Cycle (TPLC) Devices

3548

Influenza A And Influenza B Multiplex Nucleic Acid Assay

Respiratory Viral Panel Multiplex Nucleic Acid Assay.

Pre-market Notifications for OZE

K220801	ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2	Abbott Diagnostics Scarborough, Inc.
K200370	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit	Centers For Disease Control And Prevention
K190302	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping	Centers For Disease Control And Prevention
K190204	ID NOW Influenza A & B 2	Alere Scarborough, Inc.
K182513	FluChip-8G Influenza A+B Assay	InDevR, Inc.
K181736	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,	Centers For Disease Control And Prevention (CDC)
K172091	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping	Centers For Disease Control And Prevention
K171641	Accula Flu A/Flu B Test	Mesa Biotech, Inc.
K161556	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit	Centers For Disease Control And Prevention (CDC)
K153148	CDC Human Influenza Virus Real- Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping	CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
K141859	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING	CENTERS FOR DISEASE CONTROL AND PREVENTION
K140857	INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL	CENTERS FOR DISEASE CONTROL AND PREVENTION
K133869	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT	CENTER FOR DISEASE CONTROL AND PREVENTION (CDC)
K132508	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL	CENTERS FOR DISEASE CONTROL AND PREVENTION
K131728	QUIDEL MOLECULAR INFLUENZA A + B ASSAY	QUIDEL CORP.

Global Unique Device Identification Database

• 00875197005950: Influenza A And Influenza B Multiplex Nucleic Acid Assay
• 00875197005653: Influenza A And Influenza B Multiplex Nucleic Acid Assay
• 00857573006324: Influenza A And Influenza B Multiplex Nucleic Acid Assay
• 00857573006263: Influenza A And Influenza B Multiplex Nucleic Acid Assay
• 00857573006164: Influenza A And Influenza B Multiplex Nucleic Acid Assay
• B54010280: Influenza A And Influenza B Multiplex Nucleic Acid Assay
• B54010260: Influenza A And Influenza B Multiplex Nucleic Acid Assay
• 00840487100158: Influenza A and influenza B multiplex nucleic acid assay

Maude Adverse Events

SEKISUI DIAGNOSTICS SILARIS FLU PCR	MESABIOTECH, INC.	2019-05-10
SEKISUI DIAGNOSTICS SILARIS FLU PCR	MESABIOTECH, INC.	2019-05-10
SEKISUI DIAGNOSTICS SILARIS FLU PCR	MESABIOTECH, INC.	2019-05-10
SEKISUI DIAGNOSTICS SILARIS FLU PCR	MESABIOTECH, INC.	2019-05-10