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Data / Medical devices / Radioimmunoassay, Immunoreactive Insulin

Radioimmunoassay, Immunoreactive Insulin (CFP): 27 FDA-registered makers in 9 countries

27 establishments in 9 countries are registered with the FDA to make Radioimmunoassay, Immunoreactive Insulin (product code CFP, Class 1, 21 CFR 862.1405). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on November 1, 1996, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
CFP
Device class
1
Regulation
862.1405
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States10
China4
Japan4
Germany3
United Kingdom2
South Korea1
Italy1
Belgium1
Sweden1

Makers of Radioimmunoassay, Immunoreactive Insulin

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
American Laboratory Products CompanySalem, NH, United StatesManufacturer0000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer0010api.fda.gov
Beijing Hotgen Biotech Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Boditech Med Inc.Chuncheon Gangwon, South KoreaManufacturer0000api.fda.gov
Canon Medical Diagnostics Corporation Fuji Plant.SUNTO-GUN Shizuoka, JapanContract manufacturer0000api.fda.gov
Denka Co., Ltd.GOSEN-SHI Niigata, JapanManufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
DiaSorin Deutschland GmbHDietzenbach Hesse, GermanyContract manufacturer0000api.fda.gov
DiaSorin Italia S.p.A.SALUGGIA Vercelli, ItalyManufacturer0000api.fda.gov
DiaSource ImmunoAssays, SALouvain-La-Neuve Brabant Wallon, BelgiumManufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
EazebioLivermore, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Getein Biotech, Inc.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
InvitronMonmouth Monmouthshire, United KingdomManufacturer0000api.fda.gov
Mercodia ABUppsala, SwedenManufacturer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Salimetrics LLC.State College, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Shenzhen Yhlo Biotech Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shima Laboratories Co., Ltd.ITABASHI-KU Tokyo, JapanContract manufacturer, Manufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Tosoh Aia, Inc.Toyama, JapanManufacturer0000api.fda.gov

Updated November 1, 1996. 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.