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FDA 510(k)

IGX PLEX CELIAC QUALITATIVE ASSAY

K-Number: K102490 · 2011-06-02

ApplicantSqi Diagnostics Systems
Decision Date2011-06-02
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGX PLEX CELIAC QUALITATIVE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Sqi Diagnostics Systems. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K102490. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGX PLEX CELIAC QUALITATIVE ASSAY?

IGX PLEX CELIAC QUALITATIVE ASSAY is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Sqi Diagnostics Systems. The 510(k) number is K102490.

When did IGX PLEX CELIAC QUALITATIVE ASSAY receive FDA 510(k) clearance?

IGX PLEX CELIAC QUALITATIVE ASSAY received FDA 510(k) clearance on 2011-06-02, under 510(k) number K102490.

Who is the listed applicant for IGX PLEX CELIAC QUALITATIVE ASSAY?

The FDA 510(k) record lists Sqi Diagnostics Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGX PLEX CELIAC QUALITATIVE ASSAY?

The FDA product code for IGX PLEX CELIAC QUALITATIVE ASSAY is MVM.

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Other records listing Sqi Diagnostics Systems 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.

K083080IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM

Related Devices (Code: MVM)

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.

K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayPhadia ABK183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)Euroimmun Us, Inc.K123713IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISAImmco Diagnostics, Inc.K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIBio-Rad Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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