Alinity 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)

Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna

Abbott Molecular, Inc.

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

Pre-market Notification Details

Device IDK212778
510k NumberK212778
Device Name:Alinity 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)
ClassificationNucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
Applicant Abbott Molecular, Inc. 1300 E. Touhy Ave Des Plaines,  IL  60018
ContactGina Sammarco
CorrespondentGina Sammarco
Abbott Molecular, Inc. 1300 E. Touhy Ave Des Plaines,  IL  60018
Product CodeQLX  
CFR Regulation Number866.3183 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-01
Decision Date2022-07-15

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