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Mainline Technology, Inc.

Country not established

Devices
1
FDA recalls
9

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Mainline Technology, Inc. makes

Mainline Technology, Inc. manufactures the Mainline Maxie HCG urine pregnancy test, a diagnostic device designed to detect human chorionic gonadotropin (HCG) in urine samples for pregnancy confirmation.

The device falls under FDA Class II regulation and is listed via the 510(k) clearance process. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls9

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 9 recalls initiated by Mainline Technology, Inc., the earliest on 2006-11-08 and the most recent on 2009-10-07. By recorded status: 9 terminated. The reasons filed fall into these groups: labeling or instructions for use and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2009

    • 7 Oct 2009 Z-1018-2010 Unclassified (pre-2012) Terminated Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expirations dates. Distribution: Worldwide Distribution -- United States, Belgium and Switzerland.

  • 2008

    • 18 Aug 2008 Z-0525-2009 Unclassified (pre-2012) Terminated Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
    • 18 Aug 2008 Z-0526-2009 Unclassified (pre-2012) Terminated Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
    • 18 Aug 2008 Z-0527-2009 Unclassified (pre-2012) Terminated Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
    • 18 Aug 2008 Z-0528-2009 Unclassified (pre-2012) Terminated Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
    • 18 Aug 2008 Z-0529-2009 Unclassified (pre-2012) Terminated Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
    • 18 Aug 2008 Z-0530-2009 Unclassified (pre-2012) Terminated Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
    • 18 Aug 2008 Z-0531-2009 Unclassified (pre-2012) Terminated Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates. Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.

  • 2006

    • 8 Nov 2006 Z-2427-2008 Unclassified (pre-2012) Terminated Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results. Distribution: Nationwide Distribution.

Frequently asked questions

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

The registry currently lists 1 device for Mainline Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Mainline Technology, Inc.'s devices?

Among its 1 most recently registered device, Mainline Technology, Inc. has devices listed in FDA 510(k) (1 device).

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

Among its 1 most recently registered device, the classes recorded for Mainline Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Mainline Technology, Inc.?

FDA recall records list 9 recalls initiated by Mainline Technology, Inc., the most recent initiated on 7 Oct 2009. 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 Mainline Technology, Inc. in the registry?

The most recently registered devices listed for Mainline Technology, Inc. include MAINLINE MAXIE HCG URINE PREGNANCY TEST.

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