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 ID: K212778
• 510k Number: K212778
• 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)
• Classification: Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
• Applicant: Abbott Molecular, Inc. 1300 E. Touhy Ave Des Plaines, IL 60018
• Contact: Gina Sammarco
• Correspondent: Gina Sammarco; Abbott Molecular, Inc. 1300 E. Touhy Ave Des Plaines, IL 60018
• Product Code: QLX
• CFR Regulation Number: 866.3183 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-01
• Decision Date: 2022-07-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884999049697	K212778	000
00884999049505	K212778	000
00884999049499	K212778	000
00884999049482	K212778	000
00884999051300	K212778	000