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Pro-Lab, Inc.

Country not established

Devices
27

What Pro-Lab, Inc. makes

Pro-Lab, Inc. manufactures diagnostic reagents and testing kits, including the X-ACT LDC/IND for laboratory diagnostics, the D'ALA RAPID TEST for point-of-care testing, and the AMNIOTEST™ for prenatal screening. Their portfolio also includes surgical trays like the CUSTOM OPEN HEART TRAY and SUTURE TRAY, as well as microbiological supplements such as the CAMPYLOBACTER SUPPLEMENT - SKIRROW. Additional products include the ROSCO PYRR for biochemical analysis, the C.L.A.T. for laboratory testing, and the SUPLEX & SUPLEX DILUENT for medical procedures.

The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II. These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Pro-Lab, Inc. is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue27

Newest first, rows 1-27 of 27

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  • X-Act Ldc/Ind Ref K883996

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

  • D'ala Rapid Test Ref K861889

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

  • Custom Open Heart Tray Ref K850072

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

  • Rosco Pyrr Ref K894221

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

  • C.L.A.T. Ref K850308

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

  • Amniotest(Tm) Ref K914419

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

  • Suture Tray Ref K843525

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

  • Suplex & Suplex Diluent Ref K850302

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

  • C.N.V.T. Ref K850299

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

  • Campylobacter Supplement -Skirrow Ref K850306

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

  • Protect T.M. Ref K871121

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

  • O.B. Basin Set Ref K843982

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

  • X-Act Urea/Tda Ref K883995

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

  • Intravenous Start Kit Ref K843813

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

  • Legionella Reagens For Direct Fluorescent Antibody Ref K921421

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

  • Mucolyse Ref K850300

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

  • Campylobacter Supplement-Blaser/Wang Ref K850307

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

  • Master Kit A Ref K850246

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

  • Dressing Change Tray Sterile 5002 Ref K842404

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

  • Neisseria/Branhamella Differential Test Ref K870117

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

  • Yeast Dialysate Ref K850301

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

  • Venesection Tray, Adult 6050 Ref K843627

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

  • Hippurate Hydrolysis Test Ref K861888

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

  • Master Kit B Ref K861142

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

  • E. Coli 0157 Latex Test Ref K903714

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

  • Dr. Gould Hand Pack Sustom Steril Ref K842405

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

  • Prolex (Streptoccal Grouping Latex Kit) Ref K934383

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

Rows 1-27 of 27

Frequently asked questions

How many devices does Pro-Lab, Inc. have in the registry?

The registry currently lists 27 devices for Pro-Lab, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pro-Lab, Inc.'s devices?

Among its 27 most recently registered devices, Pro-Lab, Inc. has devices listed in FDA 510(k) (27 devices).

What risk classes do Pro-Lab, Inc.'s devices fall under?

Among its 27 most recently registered devices, the classes recorded for Pro-Lab, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Pro-Lab, Inc. in the registry?

The most recently registered devices listed for Pro-Lab, Inc. include X-ACT LDC/IND, D'ALA RAPID TEST, CUSTOM OPEN HEART TRAY and ROSCO PYRR.

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