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FDA 510(k)

ID NOW Influenza A & B 2

K-Number: K190204 · 2019-03-18

ApplicantAlere Scarborough, Inc.
Decision Date2019-03-18
Product CodeOZE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ID NOW Influenza A & B 2 is a medical device manufactured by Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2019-03-18 under approval number K190204. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ID NOW Influenza A & B 2?

ID NOW Influenza A & B 2 is a medical device that received FDA 510(k) clearance on 2019-03-18. It is manufactured by Alere Scarborough, Inc.. The 510(k) number is K190204.

When was ID NOW Influenza A & B 2 approved by the FDA?

ID NOW Influenza A & B 2 received FDA 510(k) clearance on 2019-03-18, under approval number K190204.

What company makes ID NOW Influenza A & B 2?

ID NOW Influenza A & B 2 is manufactured by Alere Scarborough, Inc..

What is the FDA product code for ID NOW Influenza A & B 2?

The FDA product code for ID NOW Influenza A & B 2 is OZE.

Other Devices by Alere Scarborough, Inc.

K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit K161364BinaxNOW G6PD Test K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

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Related Devices (Code: OZE)

K161556CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping KitCenters For Disease Control and Prevention (CDC) K172091CDC 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 Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and Prevention K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,Centers For Disease Control and Prevention (CDC) K171641Accula Flu A/Flu B TestMesa Biotech, Inc. K182513FluChip-8G Influenza A+B AssayIndevr, Inc. K190302CDC 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 Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping KitCenters for Disease Control and Prevention

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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