Skip to content

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 1-50 of 92

Search and filter all 92 devices
Skip device list

  • Blastomyces Dermatitidis, Antigen Ref K792680

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

  • Candida Albicans, Antiserum Ref K792713

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

  • Lacto-Phenol Analine Blue Fluid Ref K792703

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

  • Immunocard Mycoplasma Ref K934550

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

  • Histoplasma Capsulatum, Antiserum Ref K792718

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

  • Blastomyces Dermatitidis, Antiserum Ref K792685

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

  • Para-Pak Ref K811377

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

  • Immunocard Stat! E. Coli O157:H7 Ref K990263

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

  • Para-Pak(Wheatley's Trichrome Stain) Ref K792706

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

  • Para-Pak Formalin Ref K792705 Open recall

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

  • Smith's Systemic Fungal Medium Ref K792715

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

  • Anti-Globulin Control Ref K792695

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

  • Meristar-Mp Ref K905493

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

  • Ouchterlony Agar Plates Ref K792699

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

  • Immunocard(Tm) C. Difficile Ref K924979

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

  • Coccidioides Immitis, Antiserum Pos. Ref K792717

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

  • (Merifluor)Tm-Cryptosporidium Ref K870171

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

  • Micropitette Ref K792696

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

  • Premier Hsv Plus Ref K953839

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

  • Immunocard Rotavirus Ref K933587

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

  • Merifluor(Tm) Pneumocystis Ref K881608

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

  • Coccidioides Immitis, Antigen Ref K792682

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

  • Permier Histoplasma Ref K915700

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

  • Cryptococcus Neoformans Antiserum, Latex Ref K792693

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

  • Premier(Tm) H. Pylory Ref K945558

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

  • Pleascent Or Forma-Scent Ref K802506

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

  • Coccidioides Immitis, Antigen Ref K792689

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

  • Immunocard H. Pylori Ref K941560

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

  • Aspergillus Sp, Complement Fixation Ref K792700

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

  • Para-Pak Pva Ref K792714

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

  • Meriview Tm Trichomonas Ref K894246

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

  • Neutral Duffered Forma-Scent Ref K812817

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

  • Immunocard H. Pylori Ref K961508

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

  • Meritec-Strep Group A Beta-Hemolytic Ref K831599

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

  • Immunocard Stat! Rotavirus Ref K971585

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

  • Negative Control Serum Ref K792694

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

  • Para-Pak Spincon Ref K980077

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

  • Premier C. Difficile Toxin A Controls Ref K924136

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

  • Coccidioides Immitis, Antiserum, Ref K792684

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

  • Premier Platinum Hpsa Ref K980076

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

  • Merifluor(Tm) -Trichomonas Ref K892263

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

  • Premier Toxins A&B, Model 616096 Ref K993914

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

  • Meritec-Totavirus Latex Detection Procedure Ref K850269

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

  • Microsporidium Control Set Ref K943228

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

  • Premier Giardia Ref K982711

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

  • Premier Type Specific Hsv-1 Igg Elisa Test Ref K984343

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

  • Aspergillus Sp, Antiserum Positive Ref K792686

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

  • Premier Ehec Ref K950167

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

  • Premier Blastomyces Ref K923859

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

  • Merifluor Tm Pneumocystis Modification Ref K904400

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

Rows 1-50 of 92

Showing 1-50 of 92

Frequently asked questions

How many devices does Meridian Diagnostics, Inc. have in the registry?

The registry currently lists 92 devices for Meridian Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Meridian Diagnostics, Inc.'s devices?

Among its 50 most recently registered devices, Meridian Diagnostics, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Meridian Diagnostics, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Meridian Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Meridian Diagnostics, Inc. in the registry?

The most recently registered devices listed for Meridian Diagnostics, Inc. include BLASTOMYCES DERMATITIDIS, ANTIGEN, CANDIDA ALBICANS, ANTISERUM, LACTO-PHENOL ANALINE BLUE FLUID and IMMUNOCARD MYCOPLASMA.

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