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Sun Biomedical Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
17
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sun Biomedical Laboratories, Inc. makes

Sun Biomedical Laboratories, Inc. manufactures in vitro diagnostic devices designed for the qualitative detection of drugs of abuse and human chorionic gonadotropin. Their product portfolio includes dipstrip tests and panel assays for substances such as methadone, phencyclidine, cocaine, cannabinoids, morphine, methamphetamine, benzodiazepines, and barbiturates.

These devices are classified as Class II and U medical devices and are listed in the FDA 510(k) regulatory registry. The company is based in the United States.

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

Catalogue17

Newest first, rows 1-17 of 17

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Rows 1-17 of 17

FDA recalls3

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

FDA recall records list 3 recalls initiated by Sun Biomedical Laboratories, Inc., initiated on 2008-05-28. By recorded status: 3 terminated. The reasons filed fall into these groups: other reasons as filed. 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.

  • 2008

    • 28 May 2008 Z-1873-2008 Unclassified (pre-2012) Terminated Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. Distribution: Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
    • 28 May 2008 Z-1874-2008 Unclassified (pre-2012) Terminated Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. Distribution: Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
    • 28 May 2008 Z-1875-2008 Unclassified (pre-2012) Terminated Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. Distribution: Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.

Frequently asked questions

How many devices does Sun Biomedical Laboratories, Inc. have in the registry?

The registry currently lists 17 devices for Sun Biomedical Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sun Biomedical Laboratories, Inc.'s devices?

Among its 17 most recently registered devices, Sun Biomedical Laboratories, Inc. has devices listed in FDA 510(k) (17 devices).

What risk classes do Sun Biomedical Laboratories, Inc.'s devices fall under?

Among its 17 most recently registered devices, the classes recorded for Sun Biomedical Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sun Biomedical Laboratories, Inc.?

FDA recall records list 3 recalls initiated by Sun Biomedical Laboratories, Inc., the most recent initiated on 28 May 2008. 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 Sun Biomedical Laboratories, Inc. in the registry?

The most recently registered devices listed for Sun Biomedical Laboratories, Inc. include VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE, VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE, VISUALINE METHADONE DIPSTRIPTEST and VISUALINE COMBO V (COCAINE/THC) TEST.

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