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

Lactoferrin, Antigen, Antiserum, Control (DEG): 9 FDA-registered makers in 4 countries

9 establishments in 4 countries are registered with the FDA to make Lactoferrin, Antigen, Antiserum, Control (product code DEG, Class 1, 21 CFR 866.5570). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on December 4, 2007, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
DEG
Device class
1
Regulation
866.5570
Medical specialty
Immunology

Makers by country

CountryMakers
United States6
China1
Germany1
Spain1

Makers of Lactoferrin, 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
Techlab, Inc.Radford, VA, United StatesManufacturer4December 4, 2007000api.fda.gov
Techlab, Inc.Blacksburg, VA, United StatesManufacturer4December 4, 2007000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Ave Science & Technology Co., LtdChangsha Hunan, ChinaExporter to the US, Manufacturer0000api.fda.gov
American Laboratory Products CompanySalem, NH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Geroa Diagnostics Sociedad LimitadaVitoria Alava, SpainComplaint file establishment, Specification developer0000api.fda.gov
Ivd Research, LLC.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov

Updated December 4, 2007. 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.