Alinity M STI Assay

Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

Abbott Molecular, Inc.

The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Alinity M Sti Assay.

Pre-market Notification Details

Device IDK202977
510k NumberK202977
Device Name:Alinity M STI Assay
ClassificationNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Applicant Abbott Molecular, Inc. 1300 E. Touhy Des Plains,  IL  60018
ContactStacy Ferguson
CorrespondentStacy Ferguson
Abbott Molecular, Inc. 1300 E. Touhy Des Plains,  IL  60018
Product CodeQEP  
Subsequent Product CodeLSL
Subsequent Product CodeMKZ
Subsequent Product CodeOOI
Subsequent Product CodeOUY
CFR Regulation Number866.3393 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2022-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30884999050410 K202977 000
00884999048669 K202977 000
00884999048607 K202977 000
00884999048591 K202977 000

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