Data / Medical devices / Visual, Pregnancy Hcg, Prescription Use

Visual, Pregnancy Hcg, Prescription Use (JHI): 68 FDA-registered makers in 13 countries

68 establishments in 13 countries are registered with the FDA to make Visual, Pregnancy Hcg, Prescription Use (product code JHI, Class 2, 21 CFR 862.1155). 42 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 376 510(k) clearances under this code, the latest on September 22, 2026, and lists 28 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

JHI

Device class

2

Regulation

862.1155

Medical specialty

Clinical Chemistry

Makers by country

Makers of Visual, Pregnancy Hcg, Prescription Use

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated September 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.