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Data / Medical devices / Control, Plasma, Abnormal

Control, Plasma, Abnormal (GGC): 18 FDA-registered makers in 7 countries

18 establishments in 7 countries are registered with the FDA to make Control, Plasma, Abnormal (product code GGC, Class 2, 21 CFR 864.5425). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on April 5, 2011, and lists 0 recall events (0 Class I). FDA data exported November 3, 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
GGC
Device class
2
Regulation
864.5425
Medical specialty
Hematology

Makers by country

CountryMakers
United States10
Canada2
France2
Germany1
Ireland1
Switzerland1
Austria1

Makers of Control, Plasma, Abnormal

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
Diagnostica Stago, Inc.Parsippany, NJ, United StatesComplaint file establishment, Manufacturer3July 28, 2006000api.fda.gov
Precision BioLogic Inc.Dartmouth Nova Scotia, CanadaManufacturer3November 3, 2003000api.fda.gov
Diagnostica Stago - TavernyTaverny Val-d'Oise, FranceExporter to the US, Manufacturer2July 28, 2006000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesManufacturer2December 1, 1998000api.fda.gov
DSRV, Inc.Mount Olive, NJ, United StatesManufacturer1February 16, 2000000api.fda.gov
George King Bio-Medical, Inc.Overland Park, KS, United StatesManufacturer1October 5, 1995000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer, Manufacturer for export1December 15, 2010000api.fda.gov
R2 Diagnostics, Inc.South Bend, IN, United StatesManufacturer1March 16, 2007000api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer, Specification developer1February 16, 2000000api.fda.gov
Tcoag Ireland LimitedBRAY Wicklow, IrelandManufacturer1October 22, 1990000api.fda.gov
Biomedica Diagnostics Inc.Windsor Nova Scotia, CanadaManufacturer0000api.fda.gov
Hyphen Biomed SasuNEUVILLE SUR OISE Val-d'Oise, FranceManufacturer0000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer0000api.fda.gov
Pentapharm AGAesch Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Takeda Manufacturing Austria AGVIENNA Wien, AustriaContract manufacturer0000api.fda.gov
Takeda Pharmaceuticals U.S.A., Inc.Lexington, MA, United StatesSpecification developer0000api.fda.gov
Takeda Pharmaceuticals U.S.A., Inc.Cambridge, MA, United StatesSpecification developer0000api.fda.gov

Updated April 5, 2011. 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.