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FDA 510(k)

Alinity m STI Assay

K-Number: K202977 · 2022-04-29

ApplicantAbbott Molecular, Inc.
Decision Date2022-04-29
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alinity m STI Assay is a medical device manufactured by Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2022-04-29 under approval number K202977. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity m STI Assay?

Alinity m STI Assay is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Abbott Molecular, Inc.. The 510(k) number is K202977.

When was Alinity m STI Assay approved by the FDA?

Alinity m STI Assay received FDA 510(k) clearance on 2022-04-29, under approval number K202977.

What company makes Alinity m STI Assay?

Alinity m STI Assay is manufactured by Abbott Molecular, Inc..

What is the FDA product code for Alinity m STI Assay?

The FDA product code for Alinity m STI Assay is QEP.

Other Devices by Abbott Molecular, Inc.

K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) K222379Alinity m STI Assay K233349Alinity m HSV 1 & 2 / VZV K252102Alinity m HCV K243489Alinity m EBV (09N43-095) K243485Alinity m CMV

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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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