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Meridian Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices
92

What Meridian Diagnostics, Inc. makes

Meridian Diagnostics, Inc. produces diagnostic reagents and media for microbiological testing, including fungal and bacterial antigen/antiserum products, chromogenic fluids for bacterial detection, and pre-packaged culture systems. Their portfolio covers rapid immunochromatographic tests (e.g., *IMMUNOCARD* formats) for pathogens like *Mycoplasma* and *E. coli* O157:H7, as well as specialized fungal culture media and staining solutions for clinical laboratories.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with many cleared via the 510(k) pathway. Their diagnostic reagents and media are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue92

Newest first, rows 51-92 of 92

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  • Coccidioides Immitis, Antiserum Ref K792688

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

  • Para-Pak Saf Ref K792707

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

  • Meritec C. Difficile Controls Ref K924062

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

  • Coccidioides Immitis, Latex Aggluti Ref K792690

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

  • Premier-C. Difficile Toxin A Ref K903456

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

  • Meritec(Tm) - C. Difficile Latex Test System Ref K895915

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

  • Para-Pak Plus Ref K931770

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

  • Immunocard Toxin A Ref K955859

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

  • Premier Coccidioides Ref K915493

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

  • Para-Pak (C&S) Ref K792712

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

  • Candida Albicans, Antigen Ref K792716

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

  • Histoplasma Capsulatum, Antiserum Ref K792711

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

  • Aspergillus Sp., Antigen Ref K792687

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

  • Meritec(Tm)-Gc Ref K874078

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

  • Premier-Cryptococcal Antigen Ref K904393

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

  • Immunodiffusion Band Intensifying Fluid Ref K792692

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

  • Meritecastrep (Tm) Ref K821100

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

  • Histoplasma Capsulatum, Antigen Ref K792701

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

  • (Calas(Tm)) W/Add'l Reagent Calas(Tm) Pronase Ref K894845

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

  • Premier Type Specific Hsv-2 Igg Elisa Test Ref K984346

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

  • Endo-Staph Teichoic Acid Antibody Kit Ref K820531

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

  • Histoplasma Capsulatum, Mycelial Phase Ref K792708

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

  • Immunocard Mono Ref K930778

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

  • Blastomyces Dermatitidis Pos/Control Ref K792681

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

  • Koh Mounting Fluid W/Glycerol Ref K792709

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

  • Modification To: Premier Platinum Hpsa Ref K983255

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

  • Vaspar Sealant Ref K792702

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

  • Normal Globulin Reagent Ref K792697

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

  • Meritec(Tm)-Campy (Jcl) Ref K880389

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

  • Histoplasma Capsulatum, Antigen Yeast Ref K792704

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

  • Premier C. Difficile, Modification Ref K926442

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

  • Para-Pak Clean Vial Ref K792710 Open recall

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

  • Para-Pak Macro-Con Ref K860034

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

  • Merifluor(Tm)-Giardia Ref K873299

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

  • Cryptococcus Neoformans, Antigen, Ref K792691

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

  • Merifluor-Cryptosporidium/Giardia Ref K912408

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

  • Para-Pak Ref K811722

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

  • Premier Cryptosporidium Ref K982764

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

  • Blastomyces/Antigen For Immunodifusion Ref K792683

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

  • Premier Ehec Ref K953362

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

  • Histoplasma Capsulatum, Antiserum Ref K792679

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

  • Aspergillus Sp, Antiserum, Positive Ref K792698

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

Rows 51-92 of 92

Showing 51-92 of 92