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Data / Medical devices / Iga, Antigen, Antiserum, Control

Iga, Antigen, Antiserum, Control (CZP): 15 FDA-registered makers in 8 countries

15 establishments in 8 countries are registered with the FDA to make Iga, Antigen, Antiserum, Control (product code CZP, Class 2, 21 CFR 866.5510). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 54 510(k) clearances under this code, the latest on June 26, 2020, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
CZP
Device class
2
Regulation
866.5510
Medical specialty
Immunology

Makers by country

CountryMakers
United States5
Germany4
Denmark1
Singapore1
France1
Japan1
United Kingdom1
Switzerland1

Makers of Iga, Antigen, Antiserum, Control

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
Abbott LaboratoriesIrving, TX, United StatesSpecification developer1November 4, 1998000api.fda.gov
Agilent Technologies Denmark ApSGLOSTRUP Hovedstaden, DenmarkManufacturer1September 23, 1981000api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.Singapore North East, SingaporeSpecification developer1September 23, 1981000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1February 13, 2006000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceSpecification developer1June 26, 2020000api.fda.gov
Nittobo Medical Co., Ltd. Medical Development CenterKoriyama Fukushima, JapanManufacturer1November 4, 1998000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1April 5, 1996000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer1March 10, 2004000api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer, Specification developer1February 13, 2003000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
BIT Analytical Solutions GmbHSCHWALBACH/TAUNUS Hesse, GermanyContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Kent Laboratories, Inc.Bellingham, WA, United StatesManufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov

Updated June 26, 2020. 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.