Skip to content

Hillcrest Biologicals

Country not established

Devices
33

What Hillcrest Biologicals makes

Hillcrest Biologicals manufactures diagnostic test kits for detecting infectious agents, including herpes simplex, cytomegalovirus (CMV), Mycoplasma pneumoniae, Chlamydia, arboviruses, Lyme disease, polio, and Rickettsia species. Their portfolio includes complement fixation (CF) antigen tests, immunofluorescence assay (IFA) kits, and transport media for Chlamydia samples. These products are designed for laboratory use in identifying specific pathogens via serological or antigen-based methods.

The company’s diagnostic tests are classified under FDA’s Class I and Class II regulatory categories, with some devices requiring 510(k) clearance. Their products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Hillcrest Biologicals operates from the United States.

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

Catalogue33

Newest first, rows 1-33 of 33

Search and filter all 33 devices
Skip device list

  • Herpes-Iha Kit Ref K822095

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

  • Cmv Cf Antigen Ref K853277

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

  • Mycoplasma Pneumoniae Cf Antigen Ref K834338

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

  • Chlamydia Group Cf Antigen Ref K844868

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

  • Arbovirus Igm Ifa Test Ref K913618

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

  • Herpes Simplex Group Cf Antigen Ref K850609

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

  • Polio Type I Cf Antigen, & Type Ii, Iii Ref K853278

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

  • Lyme Disease Ifa (Igg) Ref K883487

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

  • Lyme Disease Ifa (Igm) Ref K883767

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

  • Echo Type 4 Cf Antigen Ref K844695

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

  • Rickettsial Igg And Igm Ifa Kit Ref K864110

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

  • Chlamydial Transport Media Ref K850124

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

  • Coxsackie A2 Cf Antigen, A4, A10 & A16 Ref K853279

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

  • Cell Culture Refeed Medium Ref K850537

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

  • Lyme Disease Igm Elisa Ref K900206

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

  • Cmv-Iha Ref K852494

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

  • Lyme Disease Elisa Ref K880476

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

  • Arbovirus Igg Ifa Test Ref K913617

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

  • Echo Type 9 Cf Antigen Ref K844967

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

  • Ebv-Vca Antibody (Igg) Ref K884591

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

  • Transport Culture Media Ref K854715

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

  • Echo Type 11 Cf Antigen Ref K853157

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

  • Ebna Antibody Ref K875170

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

  • Coxsackie B Series Cf Antigens Ref K850003

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

  • Ebv Vca Antibody (Igm) Ref K896594

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

  • Echo Type 16 Cf Antigen Ref K853156

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

  • Hillcrest Amebiasis Iha Test Ref K853448

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

  • Ebv Early Antigen (R+d) Ref K884829

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

  • Echo Type 30 Cf Antigen Ref K853165

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

  • Leptospirosis Iha Ref K880417

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

  • Viral Transport Media Ref K844747

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

  • Q Fever Igm Ifa Test Ref K922374

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

  • Q Fever Igg Ifa Test Ref K913906

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

Rows 1-33 of 33

Frequently asked questions

How many devices does Hillcrest Biologicals have in the registry?

The registry currently lists 33 devices for Hillcrest Biologicals. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hillcrest Biologicals's devices?

Among its 33 most recently registered devices, Hillcrest Biologicals has devices listed in FDA 510(k) (33 devices).

What risk classes do Hillcrest Biologicals's devices fall under?

Among its 33 most recently registered devices, the classes recorded for Hillcrest Biologicals's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Hillcrest Biologicals in the registry?

The most recently registered devices listed for Hillcrest Biologicals include HERPES-IHA KIT, CMV CF ANTIGEN, MYCOPLASMA PNEUMONIAE CF ANTIGEN and CHLAMYDIA GROUP CF ANTIGEN.

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