Data / Medical devices / Single (Specified) Analyte Controls (Assayed And Unassayed)

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX): 207 FDA-registered makers in 27 countries

Name: FDA-registered makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

207 establishments in 27 countries are registered with the FDA to make Single (Specified) Analyte Controls (Assayed And Unassayed) (product code JJX, Class 1, 21 CFR 862.1660). 58 of them have a 510(k) clearance or PMA approval on file and 9 have a recall event. The FDA has issued 493 510(k) clearances under this code, the latest on April 4, 2017, and lists 33 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: JJX
Device class: 1
Regulation: 862.1660
Medical specialty: Clinical Chemistry

Makers by country

Country	Makers
United States	94
Japan	17
South Korea	12
Taiwan	11
China	11
United Kingdom	10
Germany	10
Ireland	6
France	6
Mexico	6
Canada	3
Belgium	3
Italy	2
Poland	2
Finland	2
Netherlands	1
Switzerland	1
Spain	1
New Zealand	1
Philippines	1
Norway	1
Denmark	1
Singapore	1
Vietnam	1
India	1
Sweden	1
Australia	1

Makers of Single (Specified) Analyte Controls (Assayed And Unassayed)

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.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Siemens Healthcare Diagnostics Products Limited	LLANBERIS Wales, United Kingdom	Manufacturer, Specification developer	27	April 13, 2015	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	17	July 17, 2015	0	api.fda.gov
Cliniqa Corporation	San Marcos, CA, United States	Contract manufacturer, Manufacturer	11	May 18, 2012	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	E Walpole, MA, United States	Manufacturer	10	January 27, 2015	2	api.fda.gov
Randox Laboratories Limited	CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom	Contract manufacturer, Manufacturer, Repackager or relabeler	8	July 26, 2013	0	api.fda.gov
Tosoh Aia, Inc.	Toyama, Japan	Manufacturer	7	December 16, 2014	0	api.fda.gov
Immunodiagnostic Systems Ltd.	Boldon Colliery Durham, United Kingdom	Manufacturer	5	May 17, 2016	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Manufacturer, Specification developer	5	September 27, 2004	3	api.fda.gov
Ortho-Clinical Diagnostics	Pencoed Bridgend, United Kingdom	Manufacturer	5	September 27, 2004	0	api.fda.gov
Roche Diagnostics GMBH	MANNHEIM Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler	5	April 4, 2017	0	api.fda.gov
Quantimetrix Corp.	Redondo Beach, CA, United States	Contract manufacturer, Manufacturer	4	May 10, 2012	0	api.fda.gov
ABBOTT GmbH	Wiesbaden Hesse, Germany	Exporter to the US, Manufacturer, Specification developer	3	October 26, 2016	0	api.fda.gov
Beckman Coulter, Inc.	Chaska, MN, United States	Manufacturer	3	November 4, 2011	0	api.fda.gov
Bio-Rad Laboratories Inc.	Irvine, CA, United States	Manufacturer	3	January 9, 2013	0	api.fda.gov
Bio-Rad Laboratories Inc.	Irvine, CA, United States	Manufacturer	3	January 9, 2013	0	api.fda.gov
Eurotrol B.V.	EDE Gelderland, Netherlands	Manufacturer	3	March 24, 2006	0	api.fda.gov
Beckman Coulter, Inc.	Brea, CA, United States	Specification developer	2	July 6, 1998	4	api.fda.gov
Bionostics, Inc.	Devens, MA, United States	Contract manufacturer, Manufacturer	2	February 10, 2011	0	api.fda.gov
Diasorin Inc.	Stillwater, MN, United States	Contract manufacturer, Manufacturer	2	June 30, 2016	0	api.fda.gov
DiaSorin Italia S.p.A.	SALUGGIA Vercelli, Italy	Manufacturer	2	June 30, 2016	0	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation MIE Office	Komono-cho, Mie-gun, Japan	Manufacturer	2	February 11, 2003	0	api.fda.gov
FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)	Amagasaki-shi Hyogo, Japan	Specification developer	2	February 11, 2003	0	api.fda.gov
Fisher Diagnostics	Middletown, VA, United States	Contract manufacturer, Manufacturer, Manufacturer for export	2	February 18, 1993	0	api.fda.gov
Helena Laboratories, Corp.	Beaumont, TX, United States	Manufacturer, Manufacturer for export	2	March 30, 1995	1	api.fda.gov
LGC Clinical Diagnostics, Inc.	Cumberland Foreside, ME, United States	Manufacturer	2	June 14, 2013	0	api.fda.gov
Microgenics Corporation	Fremont, CA, United States	Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer	2	August 16, 2004	1	api.fda.gov
Nova Biomedical Corporation	Waltham, MA, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Specification developer	2	May 7, 2004	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	San Diego, CA, United States	Specification developer	2	November 26, 1997	0	api.fda.gov
Qualigen, Inc.	Carlsbad, CA, United States	Manufacturer	2	April 2, 2007	0	api.fda.gov
Quidel Corp.	San Diego, CA, United States	Complaint file establishment, Manufacturer	2	November 26, 1997	0	api.fda.gov
Quidel Cardiovascular Inc.	San Diego, CA, United States	Manufacturer, Manufacturer for export	2	March 2, 2000	0	api.fda.gov
SA Scientific, Ltd	San Antonio, TX, United States	Manufacturer	2	January 17, 1995	0	api.fda.gov
Abbott Ireland Diagnostics Division	Longford, Ireland	Manufacturer, Repackager or relabeler	1	August 18, 2004	0	api.fda.gov
Abbott Point Of Care Canada Limited	Ottawa Ontario, Canada	Manufacturer, Specification developer	1	May 18, 2012	0	api.fda.gov
Acon Laboratories, Inc.	San Diego, CA, United States	Contract manufacturer, Manufacturer, Specification developer	1	April 9, 2012	0	api.fda.gov
Ascensia Diabetes Care Holdings AG	Basel Basel-Stadt, Switzerland	Specification developer	1	September 23, 2015	0	api.fda.gov
Analytical Control Systems	Fishers, IN, United States	Manufacturer	1	April 20, 1994	0	api.fda.gov
Ascensia Diabetes Care Poland Sp. z o.o.	Warszawa Mazowieckie, Poland	Specification developer	1	September 23, 2015	0	api.fda.gov
Ascensia Diabetes Care US Inc.	Parsippany, NJ, United States	Specification developer	1	September 23, 2015	0	api.fda.gov
Ascensia Diabetes Care US Inc.	Valhalla, NY, United States	Complaint file establishment, Specification developer	1	September 23, 2015	0	api.fda.gov
Biochemical Diagnostics, Inc.	Edgewood, NY, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	1	March 29, 2005	1	api.fda.gov
Biokit S.A.	LLISSA D AMUNT Barcelona, Spain	Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer	1	January 26, 2006	0	api.fda.gov
Bionime Corporation	Taichung City, Taiwan	Manufacturer	1	October 24, 2013	0	api.fda.gov
Canterbury Scientific Ltd.	Christchurch Canterbury, New Zealand	Manufacturer	1	December 9, 2004	0	api.fda.gov
DRG Instruments GMBH	MARBURG Hesse, Germany	Complaint file establishment, Contract manufacturer, Manufacturer	1	September 6, 2011	0	api.fda.gov
Diazyme Laboratories, Inc.	Poway, CA, United States	Manufacturer	1	October 29, 2004	0	api.fda.gov
Kova International Inc	Garden Grove, CA, United States	Manufacturer	1	January 26, 1993	0	api.fda.gov
LifeScan U.S. LLC	Malvern, PA, United States	Specification developer	1	February 10, 2011	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, United States	Manufacturer	1	June 22, 1993	0	api.fda.gov
Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC.	Cortlandt Manor, NY, United States	Specification developer	1	April 29, 1992	0	api.fda.gov
Qiagen	Germantown, MD, United States	Manufacturer	1	February 2, 2004	0	api.fda.gov
Sentinel CH. SPA	Milano, Italy	Manufacturer, Repackager or relabeler	1	April 20, 1994	1	api.fda.gov
Sekisui Diagnostics, LLC	San Diego, CA, United States	Manufacturer	1	December 6, 1995	0	api.fda.gov
Siemens Healthcare Diagnostics Inc	East Walpole, MA, United States	Manufacturer, Manufacturer for export	1	July 17, 2015	0	api.fda.gov
Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, Germany	Manufacturer	1	October 18, 2001	0	api.fda.gov
Taidoc Technology Corporation	New Taipei City, Taiwan	Contract manufacturer, Manufacturer	1	July 29, 2010	0	api.fda.gov
Techno-Path Manufacturing Ltd.	Ballina Tipperary, Ireland	Exporter to the US, Manufacturer	1	October 26, 2016	0	api.fda.gov
Trinity Biotech, Plc	BRAY Wicklow, Ireland	Manufacturer	1	October 20, 1987	0	api.fda.gov
Aalto Scientific Ltd.	Eatonton, GA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Abbott Diabetes Care Inc.	Alameda, CA, United States	Complaint file establishment, Specification developer	0		1	api.fda.gov
Abbott Diabetes Care Limited	WITNEY OXON Oxfordshire, United Kingdom	Manufacturer	0		0	api.fda.gov
Abbott Ireland	Sligo, Ireland	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Abbott Laboratories	Irving, TX, United States	Specification developer	0		0	api.fda.gov
Abbott Laboratories	Abbott Park, IL, United States	Specification developer	0		8	api.fda.gov
Acon Biotech (hangzhou) Co., Ltd.	HANGZHOU Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Agamatrix	Derry, NH, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Aidian OY	ESPOO Uusimaa, Finland	Manufacturer	0		0	api.fda.gov
Alfa Wassermann	West Caldwell, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Alliance International Medical Co., Ltd.	New Taipei City, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Apex Biotechnology Corp.	HSINCHU Hsinchu(County), Taiwan	Exporter to the US, Manufacturer, Specification developer	0		0	api.fda.gov
ARKRAY Factory, Inc.	Koka-shi Shiga, Japan	Manufacturer	0		0	api.fda.gov
ARKRAY Industry West Inc.	Rosario Cavite, Philippines	Manufacturer	0		0	api.fda.gov
Arkray, Inc.	Kamigyo-ku Kyoto, Japan	Specification developer	0		0	api.fda.gov
Axis-Shield Diagnostics, Ltd.	DUNDEE Scotland, United Kingdom	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Abbott Diagnostics Technologies AS	Oslo, Norway	Manufacturer	0		0	api.fda.gov
Agilent Technologies Denmark ApS	GLOSTRUP Hovedstaden, Denmark	Manufacturer	0		0	api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.	Singapore North East, Singapore	Specification developer	0		0	api.fda.gov
All Medicus Co., Ltd.	Anyang-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
B.R.A.H.M.S GmbH	HENNIGSDORF Brandenburg, Germany	Specification developer	0		0	api.fda.gov
BD Rapid Diagnostics (Suzhou) Co. Ltd.	China (Jiangsu) Pilot Free Trade Zone Suzhou Area, China	Manufacturer	0		0	api.fda.gov
Beckman Coulter, Inc.	Carlsbad, CA, United States	Contract manufacturer	0		0	api.fda.gov
Becton, Dickinson & Co.	San Diego, CA, United States	Specification developer	0		0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Beijing Genesee Biotech, Inc.	Beijing, China	Manufacturer	0		0	api.fda.gov
Bialex Lab	Wichita Falls, TX, United States	Manufacturer	0		0	api.fda.gov
Bio-Rad Laboratories, Inc.	Woodinville, WA, United States	Contract manufacturer	0		0	api.fda.gov
Biorex Labs LLC	Broadview Heights, OH, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Boditech Med Inc.	Chuncheon Gangwon, South Korea	Contract manufacturer, Manufacturer	0		0	api.fda.gov
BOI(VIETNAM) Company Ltd	Nenh Ward Bac Ninh, Vietnam	Contract manufacturer	0		0	api.fda.gov
Bio-Rad Laboratories, Inc.	Hercules, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
BiometerPlus USA, Inc.	Fremont, CA, United States	Manufacturer	0		0	api.fda.gov
Cambridge Sensors Limited	HUNTINGDON, Cambridgeshire, United Kingdom	Manufacturer	0		0	api.fda.gov
Care Living Diagnostics Inc	South Setauket, NY, United States	Specification developer	0		0	api.fda.gov
Catachem, Inc.	Oxford, CT, United States	Manufacturer	0		0	api.fda.gov
Cezanne SAS	NIMES Gard, France	Contract manufacturer	0		0	api.fda.gov
Chromsystems Instruments & Chemicals GMBH	Gräfelfing Bavaria, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Clinical Innovations, LLC	Murray, UT, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Cone Bioproducts Of Seguin LLC	Seguin, TX, United States	Contract manufacturer	0		0	api.fda.gov
CTK Biotech, Inc.	Poway, CA, United States	Manufacturer	0		0	api.fda.gov
Canon Medical Diagnostics Corporation Fuji Plant.	SUNTO-GUN Shizuoka, Japan	Contract manufacturer	0		0	api.fda.gov
Changsha Sinocare Inc.	Changsha Hunan, China	Manufacturer	0		0	api.fda.gov
Denka Co., Ltd.	GOSEN-SHI Niigata, Japan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Diagam S.A.	Ghislenghien Hainaut, Belgium	Manufacturer	0		0	api.fda.gov
DIAGENODE s.a.	Seraing Liege, Belgium	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Diagnostica Stago, Inc.	Parsippany, NJ, United States	Manufacturer for export	0		0	api.fda.gov
Diasys Diagnostic Systems GMBH	Holzheim Rhineland-Palatinate, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Dirui Industrial Co., Ltd.	CHANGCHUN Jilin, China	Manufacturer	0		0	api.fda.gov
DiaSorin Deutschland GmbH	Dietzenbach Hesse, Germany	Contract manufacturer	0		0	api.fda.gov
DiaSorin Molecular LLC	Cypress, CA, United States	Manufacturer	0		0	api.fda.gov
ELITechGroup Inc	Logan, UT, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Eps Bio Technology Corp.	Hsinchu Hsinchu(County), Taiwan	Manufacturer	0		0	api.fda.gov
Fort Worth Diagnostics LLC	Fort Worth, TX, United States	Manufacturer	0		0	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office	MINAMIASHIGARA-SHI Kanagawa, Japan	Contract manufacturer	0		0	api.fda.gov
Flextronics Industrial (Shenzhen) Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Flextronics Manufacturing Aguascalientes, S.A de C.V	Aguascalientes, Mexico	Contract manufacturer	0		0	api.fda.gov
Fujirebio Diagnostics, Inc.	Malvern, PA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Fujirebio Diagnostics, Inc.	Seguin, TX, United States	Manufacturer	0		0	api.fda.gov
Fujirebio Europe N.V.	GHENT Oost-Vlaanderen, Belgium	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Fujirebio Inc.	Sagamihara-shi Kanagawa, Japan	Manufacturer	0		0	api.fda.gov
Germaine Laboratories, Inc.	San Antonio, TX, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
GL Diabetes Corporation	San Diego, CA, United States	Contract manufacturer	0		0	api.fda.gov
Global Instrumentation Corp.	New Taipei, Taiwan	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Golden Smart Home Technology Corp.	Hsinchu City Hsinchu(City), Taiwan	Manufacturer	0		0	api.fda.gov
HMD Biomedical, Inc.	Hsinchu County Hsinchu(County), Taiwan	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Horiba Abx SAS	MONTPELLIER Herault, France	Manufacturer, Specification developer	0		0	api.fda.gov
Human Metabolomics Institute, Inc.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
High Technology, Inc.	North Attleboro, MA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Hologic, Inc.	San Diego, CA, United States	Manufacturer	0		0	api.fda.gov
I-SENS Songdo Factory 2	lncheon Incheon, South Korea	Manufacturer	0		0	api.fda.gov
I-Sens, Inc.	Seoul, South Korea	Specification developer	0		0	api.fda.gov
Ibl International GMBH	Hamburg, Germany	Manufacturer	0		0	api.fda.gov
Immunodiagnostic Systems France SAS	POUILLY EN AUXOIS Cote-d'Or, France	Manufacturer	0		0	api.fda.gov
Inova Diagnostics, Inc.	San Diego, CA, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Instrumentation Laboratory Co.	Bedford, MA, United States	Specification developer	0		0	api.fda.gov
Immunotech SAS, a Beckman Coulter company	MARSEILLE, CEDEX 9 Bouches-du-Rhone, France	Contract manufacturer	0		0	api.fda.gov
Integra Biotechnical, SA de CV	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Kamiya Biomedical Company LLC	Tukwila, WA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Laboratorios Scantibodies S.A. De C.V.	TECATE Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
LGC Clinical Diagnostics, Inc.	Milford, MA, United States	Manufacturer	0		0	api.fda.gov
LGC Clinical Diagnostics, Inc.	Gaithersburg, MD, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Lords Mark Industries Ltd.	Daman and Diu Dadra and Nagar Haveli, India	Manufacturer	0		0	api.fda.gov
Maq-Ops, S. De R.L.	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Maxim Biomedical Inc.	Rockville, MD, United States	Contract manufacturer	0		0	api.fda.gov
Medica Corp.	Bedford, MA, United States	Manufacturer	0		0	api.fda.gov
Mediusa Inc.	Los Angeles, CA, United States	Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Microbix	Mississauga Ontario, Canada	Exporter to the US, Manufacturer	0		0	api.fda.gov
Nanoentek Inc	Hwaseong Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Nanoentek Inc	Seoul, South Korea	Specification developer	0		0	api.fda.gov
Nittobo Medical Co., Ltd. Medical Development Center	Koriyama Fukushima, Japan	Contract manufacturer	0		0	api.fda.gov
Nova Biomedical Corporation Diabetes Products	Billerica, MA, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	0		0	api.fda.gov
Nowdiagnostics, Inc.	Springdale, AR, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant	Izunokuni-shi Shizuoka, Japan	Manufacturer	0		0	api.fda.gov
Nova Biomedical Corporation	Billerica, MA, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	0		0	api.fda.gov
Ok Biotech Co., Ltd.	HSINCHU CITY Hsinchu(County), Taiwan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Manufacturer	0		0	api.fda.gov
OSANG Healthcare CO., LTD.	ANYANG Gyeonggi, South Korea	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Osang LLC	S Pasadena, CA, United States	Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Phadia AB	Uppsala, Sweden	Complaint file establishment, Manufacturer	0		0	api.fda.gov
PHC Corporation	TOON Ehime, Japan	Contract manufacturer	0		0	api.fda.gov
PHC Corporation	MIMA Tokushima, Japan	Contract manufacturer	0		0	api.fda.gov
Precision Diabetes, Inc.	Raleigh, NC, United States	Specification developer	0		0	api.fda.gov
Princeton Biomeditech Corp.	Monmouth Jct, NJ, United States	Manufacturer	0		0	api.fda.gov
Princeton BioMeditech Corp.	Plainsboro, NJ, United States	Manufacturer	0		0	api.fda.gov
Princeton BioMeditech Corp.	Skillman, NJ, United States	Manufacturer	0		0	api.fda.gov
Randox Laboratories Limited	ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Rasimo Systems LLC	Raleigh, NC, United States	Specification developer	0		0	api.fda.gov
Roche Diabetes Care, Inc.	Indianapolis, IN, United States	Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Roche Diagnostics GMBH	PENZBERG Bavaria, Germany	Specification developer	0		0	api.fda.gov
RR Donnelley-Supply Chain Solutions	Plover, WI, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
RR Donnelley GTS Poland Sp. z o.o.	Lodz Lodzkie, Poland	Contract manufacturer	0		0	api.fda.gov
RR Donnelley Global Turnkey Solutions	Juarez Chihuahua, Mexico	Contract manufacturer	0		0	api.fda.gov
Rosie Connectivity Solutions, Inc.	Savannah, GA, United States	Remanufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
SD Biosensor, Inc.	Suwon-si Gyeonggi, South Korea	Specification developer	0		0	api.fda.gov
SD Biosensor, Inc.	Cheongju-si Chungbuk, South Korea	Manufacturer	0		0	api.fda.gov
Sebia	EVRY Essonne, France	Manufacturer	0		0	api.fda.gov
Sejoy Biomedical Co., Ltd.	Hangzhou City Zhejiang, China	Manufacturer	0		0	api.fda.gov
SEKISUI MEDICAL CO., LTD. Tsukuba Plant	Ryugasaki-shi Ibaraki, Japan	Contract manufacturer	0		0	api.fda.gov
Sequitur Health Corp.	Phoenix, AZ, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
SG BioScience, INC	Dongdaemun-gu Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Shima Laboratories Co., Ltd.	ITABASHI-KU Tokyo, Japan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Speedx Pty Ltd	Eveleigh New South Wales, Australia	Complaint file establishment, Exporter to the US, Manufacturer	0		0	api.fda.gov
Stanbio Laboratory	Boerne, TX, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
STS Corporation	Duluth, GA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Sekisui Diagnostics P.E.I. Inc.	CHARLOTTETOWN Prince Edward Island, Canada	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.	SWORDS Dublin(County), Ireland	Manufacturer	0		0	api.fda.gov
Spartronics Watertown LLC	Watertown, SD, United States	Contract manufacturer	0		0	api.fda.gov
Takasaki Plant, Nippon Kayaku Co., Ltd.	TAKASAKI-SHI Gunma, Japan	Contract manufacturer	0		0	api.fda.gov
Teco Diagnostics	Anaheim, CA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
The Binding Site	Kings Norton Birmingham, United Kingdom	Manufacturer	0		0	api.fda.gov
Tianjin Empecs Medical Device Co., Ltd.	Tianjin, China	Manufacturer	0		0	api.fda.gov
Tyson Bioresearch, Inc.	Zhunan Township Miaoli, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Teladoc Health, Inc. - Lewisville	Lewisville, TX, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Telcare, LLC	Linwood, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
The Binding Site Group Ltd.	Birmingham, United Kingdom	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Tosoh Hi-Tec, Inc.	Yamaguchi, Japan	Manufacturer	0		0	api.fda.gov
Trukera Medical	Temecula, CA, United States	Specification developer	0		0	api.fda.gov
Victorch Meditek, Inc.	San Diego, CA, United States	Manufacturer for export	0		0	api.fda.gov
Visgeneer, Inc.	HSINCHU CITY Hsinchu(City), Taiwan	Manufacturer	0		0	api.fda.gov
Vivachek Biotech (hangzhou) Co., Ltd	Hangzhou, Zhuji Zhejiang, China	Manufacturer	0		0	api.fda.gov
VitalScientific	SEES Normandie, France	Manufacturer	0		0	api.fda.gov
Wallac OY	TURKU Varsinais-Suomi, Finland	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Waters Technologies Ireland, Ltd.	DRINAGH Wexford, Ireland	Specification developer	0		0	api.fda.gov
Yasee Biomedical Inc	QINGDAO Shandong, China	Contract manufacturer	0		0	api.fda.gov
i-SENS Songdo Factory	Incheon, South Korea	Manufacturer	0		0	api.fda.gov
i-SENS Wonju Factory	Wonju-si Gangwon, South Korea	Manufacturer	0		0	api.fda.gov

Updated April 4, 2017. 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.