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Advandx, Inc.

United StatesFDA applicant, unverified

Devices
22
FDA recalls
7

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue22

Newest first, rows 1-22 of 22

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  • mecA XpressFISH® KT601

    None Registry: GUDID Class:II

  • C. Albicans Pna Fish Ref K092655

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • E. Coli Pna Fish Ref K082068

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • E.coli/P. Aeruginosa Pna Fish Ref K092236

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • C. Albicans Pna Fish Ref K062461

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gbs Pna Fish Ref K082612

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gnr Traffic Light Pna Fish Ref K101558

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ek/P. Aeruginosa Pna Fish Ref K092393

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • S. Aureus Pna Fish Ref K091827

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gram-Negative Quickfish Bc Ref K123418

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Enterococcus Quickfish Bc Ref K121991

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • S. Aureus Pna Fish Ref K060099

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Enterococcus Faecalis Pna Fish Ref K063127

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Yeast Traffic Light Pna Fish Ref K080719

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • C. Albicans/C. Glabrata Pna Fish Ref K092784

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • E.coli/P. Aeruginosa Pna Fish Ref K081309

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Avandx E. Faecalis/Oe Pna Fish Culture Identification Kit Ref K083074

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Staphylococcus Quickfish Bc Ref K113371

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • S. Aureus/Cns Pna Fish, Model KT005 Ref K092166

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ek/P. Aeruginosa Pna Fish Ref K081433

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Meca Xpressfish Ref K140619

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Yeast Traffic Light Pna Fish Ref K093024

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-22 of 22

Company details

DUNS number
145416900
Phone
+1(781)376-0009

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2014

    • 4 Jul 2014 Z-2138-2014 Class II Terminated Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC Distribution: Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA. Submission number: K113371

  • 2013

    • 11 Dec 2013 Z-0619-2014 Class III Terminated Kits incompatible with certain fluorescence microscope light sources Distribution: Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark. Submission number: K123418

  • 2012

    • 14 Sep 2012 Z-0112-2013 Class II Terminated GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva Distribution: Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
    • 14 Sep 2012 Z-0116-2013 Class II Terminated Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal Distribution: Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.

  • 2010

    • 8 Oct 2010 Z-0491-2011 Unclassified (pre-2012) Terminated Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK /P. aeruginosa PNA FISH to produce a false positive red signal Distribution: Worldwide Distribution - USA including IL, MI, NY, and PA and the country of Denmark Submission number: K092393
    • 6 Oct 2010 Z-0490-2011 Unclassified (pre-2012) Terminated Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal. Distribution: Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK. Submission number: K092236
    • 8 Jun 2010 Z-2315-2010 Unclassified (pre-2012) Terminated Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal. Distribution: Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European). Submission number: K083074

Frequently asked questions

How many devices does Advandx, Inc. have in the registry?

The registry currently lists 22 devices for Advandx, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Advandx, Inc.'s devices?

Among its 22 most recently registered devices, Advandx, Inc. has devices listed in FDA 510(k) (21 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Advandx, Inc.'s devices fall under?

Among its 22 most recently registered devices, the classes recorded for Advandx, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Advandx, Inc.?

FDA recall records list 7 recalls initiated by Advandx, Inc., the most recent initiated on 4 Jul 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Advandx, Inc. in the registry?

The most recently registered devices listed for Advandx, Inc. include mecA XpressFISH® KT601, C. ALBICANS PNA FISH, E. COLI PNA FISH and E.COLI/P. AERUGINOSA PNA FISH.

Generated automatically from registry data and not verified by a human reviewer.