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Austin Biological Laboratories

Country not established

Devices
45

What Austin Biological Laboratories makes

Austin Biological Laboratories manufactures diagnostic reagents and testing systems for microbiological identification, including lyophilized microorganisms, biochemical test strips (e.g., indole, nitrate, bile esculin), and antimicrobial susceptibility panels (e.g., Precept™ Ticarcilin/Clavulanic Acid, Precept™ Ceftizoxime). Their portfolio also includes systems for enteric pathogen detection, such as the Austin Enteric System, and biochemical assays for identifying bacteria like *Haemophilus* species.

The company’s products are regulated under FDA’s Class I, Class II, and Class III device classifications, with many cleared via the 510(k) pathway. Their diagnostic reagents and testing systems are listed in the FDA’s 510(k) database, and the company operates from the United States.

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

Catalogue45

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  • Rim Spot Indole Ref K842097

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

  • Rim-Haemophilus 2 Ref K832239

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

  • Precept (Tm) Ticarcillin/Clavulanic Acid Ref K864069

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

  • Rim - Nitrate Test Ref K841270

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

  • Rim-Bile Esculin Test Ref K841262

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

  • Austin Enteric System Ref K860194

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

  • Precept Avgmentin Ref K853263

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

  • Rim-Urea Ref K843571

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

  • Precept Ceftizoxime Ref K862560

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

  • Precept Tm Carbenicillin Ref K853685

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

  • Lyophilized Microorganisms Ref K831653

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

  • Spectrum-10 Ref K831672

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

  • Precept Ceftriaxone Ref K853273

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

  • Rim Strep Kit Ref K842451

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

  • Rim Beta Lactamase Test Ref K831654

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

  • Precept Netilmicin 32-13 Ref K853687

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

  • Precept(Tm) Ciprofloxacin Ref K874727

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

  • Precept Ceftazidime Ref K862446

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

  • Precept Tm Amikacin Ref K853686

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

  • Rim Gardnerella Vaginalis Kit Ref K841460

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

  • Precept Trimethoprim/Sulfamethoxazole Ref K860195

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

  • Anaerobe Kit Ref K850052

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

  • Precept Amoxicillin/Clavvlanic Acid (Augmentin) Ref K854577

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

  • Rim H2S Ref K842098

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

  • Austin Nonfermenter Kit Ref K870769

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

  • Precept Tm Moxalactam Ref K853689

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

  • Precept Tm Mezlocillin Ref K850833

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

  • Rim-Haemophilus 1 & 2 Ref K832051

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

  • Precept Tm Tobramycin Ref K853688

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

  • Rim 6.5% Nacl Ref K841508

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

  • Precept Kanamycin Ref K853684

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

  • Xact Neisseria Ref K880511

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

  • Precept Cefoperazone Ref K853596

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

  • Rapid Identifi-Method Neisseria Kit Ref K830968

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

  • Rim-Dnase Kit Ref K841389

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

  • Precept Erythromycin Ref K853053

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

  • Spectrum-10 Ref K831655

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

  • Rim Onpg Kit Ref K841329

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

  • Modification Of Abl Mic-10 Precept Sys Ref K843612

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

  • Rim Gram Reaction Swab Ref K840252

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

  • Rime Coli Kit Ref K832587

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

  • Rim-Hippurate Ref K841277

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

  • Rim-Camp Test Ref K831674

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

  • Oxy-Swab Ref K831673

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

  • Precept Methicillin Ref K853772

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

Rows 1-45 of 45

Frequently asked questions

How many devices does Austin Biological Laboratories have in the registry?

The registry currently lists 45 devices for Austin Biological Laboratories. Devices recorded under merged duplicate company entries are counted once.

Which registries list Austin Biological Laboratories's devices?

Among its 45 most recently registered devices, Austin Biological Laboratories has devices listed in FDA 510(k) (45 devices).

What risk classes do Austin Biological Laboratories's devices fall under?

Among its 45 most recently registered devices, the classes recorded for Austin Biological Laboratories's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Austin Biological Laboratories in the registry?

The most recently registered devices listed for Austin Biological Laboratories include RIM SPOT INDOLE, RIM-HAEMOPHILUS 2, PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID and RIM - NITRATE TEST.

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