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FDA 510(k)

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

K-Number: K192046 · 2019-10-28

ApplicantDiaSorin, Inc.
Decision Date2019-10-28
Product CodeQFO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2019-10-28 under 510(k) number K192046. The device is classified under product code QFO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is a medical device that received FDA 510(k) clearance on 2019-10-28. The listed applicant is DiaSorin, Inc.. The 510(k) number is K192046.

When did LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set receive FDA 510(k) clearance?

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set received FDA 510(k) clearance on 2019-10-28, under 510(k) number K192046.

Who is the listed applicant for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

The FDA product code for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is QFO.

Other records listing DiaSorin, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P250039ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGMPMA P220034ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGGK260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXPMA P180047TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSISPMA P190017Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)PMA P180049Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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Related Devices (Code: QFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderChembio Diagnostic SystemsK191578ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality ControlSiemens Healthcare Diagnostics, Inc.

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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