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Data / Medical devices / Test, Cystatin C

Test, Cystatin C (NDY): 16 FDA-registered makers in 9 countries

16 establishments in 9 countries are registered with the FDA to make Test, Cystatin C (product code NDY, Class 2, 21 CFR 862.1225). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on May 16, 2025, and lists 4 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 GermanyWatch this device
Product code
NDY
Device class
2
Regulation
862.1225
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
Germany3
United States3
United Kingdom3
Japan2
Norway1
Denmark1
Singapore1
Italy1
Switzerland1

Makers of Test, Cystatin C

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
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer3May 12, 2017000api.fda.gov
Gentian ASMoss Ostfold, NorwayManufacturer2August 20, 2008010api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer2July 27, 2016000api.fda.gov
Agilent Technologies Denmark ApSGLOSTRUP Hovedstaden, DenmarkManufacturer1September 3, 2004000api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.Singapore North East, SingaporeSpecification developer1September 3, 2004000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer1April 8, 2010000api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer1September 28, 2010000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1March 11, 2009000api.fda.gov
Sentinel CH. SPAMilano, ItalyManufacturer1May 16, 2025000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1May 25, 2018000api.fda.gov
The Binding SiteKings Norton Birmingham, United KingdomManufacturer1January 24, 2008000api.fda.gov
Tosoh Aia, Inc.Toyama, JapanManufacturer1September 14, 2010000api.fda.gov
The Binding Site Group Ltd.Birmingham, United KingdomComplaint file establishment, Manufacturer1January 24, 2008000api.fda.gov
Nittobo Medical Co., Ltd. Medical Development CenterKoriyama Fukushima, JapanContract manufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov

Updated May 16, 2025. 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.