Alinity m HSV 1 & 2 / VZV
K-Number: K233349 · 2024-05-03
ApplicantAbbott Molecular, Inc.
Decision Date2024-05-03
Product CodePGI
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Alinity m HSV 1 & 2 / VZV is a medical device manufactured by Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2024-05-03 under approval number K233349. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alinity m HSV 1 & 2 / VZV?
Alinity m HSV 1 & 2 / VZV is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by Abbott Molecular, Inc.. The 510(k) number is K233349.
When was Alinity m HSV 1 & 2 / VZV approved by the FDA?
Alinity m HSV 1 & 2 / VZV received FDA 510(k) clearance on 2024-05-03, under approval number K233349.
What company makes Alinity m HSV 1 & 2 / VZV?
Alinity m HSV 1 & 2 / VZV is manufactured by Abbott Molecular, Inc..
What is the FDA product code for Alinity m HSV 1 & 2 / VZV?
The FDA product code for Alinity m HSV 1 & 2 / VZV is PGI.
Other Devices by Abbott Molecular, Inc.
Related Devices (Code: PGI)
K162451Solana HSV 1+2/VZV AssayQuidel Corporation
K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup
K173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackDiasorin Molecular, LLC
K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC
K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel Corporation
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.