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Wien Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
13

What Wien Laboratories, Inc. makes

Wien Laboratories, Inc. makes test sets for various substances, including 17-hydroxyprogesterone, testosterone, androstenedione, progesterone, digoxin, dehydroepiandrosterone, and others. These test sets are used to measure the levels of these substances in the body. The company's products include test sets for hormones, such as SHBG and estriol, as well as for certain medications, like doxepin and protriptyline.

The company's portfolio is regulated as Class I and Class II devices and is listed in the FDA 510(k) registry. The company is based in the US.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

Newest first, rows 1-13 of 13

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  • 17-Hydroxyprogesterone Test Set Ref K771729

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

  • 125I-Testosterone Test Set Ref K802728

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

  • Androstenedione Test Set 125I Ref K832452

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

  • Shbg Ref K912850

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

  • Progesterone Test Set 125I 17-Oh Ref K834246

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

  • 125I Digoxin Test Set Ref K772306

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

  • 125 I-Dehydroepiandrosterone Sulfate Ref K823200

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

  • I-Estriol Test Set Ref K781599

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

  • Doxepin Tri-Cy Test Set Ref K821652

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

  • Dhea Test Set Ref K771793

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

  • Protriptyline Tri-Cy Test Set Ref K821653

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

  • Dhea-Sulfate Test Set Ref K792041

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

  • Test Set, 125 I-Digoxin Ref K781834

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

Rows 1-13 of 13

Frequently asked questions

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

The registry currently lists 13 devices for Wien Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Wien Laboratories, Inc.'s devices?

Among its 13 most recently registered devices, Wien Laboratories, Inc. has devices listed in FDA 510(k) (13 devices).

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

Among its 13 most recently registered devices, the classes recorded for Wien Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Wien Laboratories, Inc. include 17-HYDROXYPROGESTERONE TEST SET, 125I-TESTOSTERONE TEST SET, ANDROSTENEDIONE TEST SET 125I and SHBG.

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