Thermo Fisher Scientific

Entity profile compiled from public source records

Public Record Profile Registrations: 15 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 1000087290, 1000515493, 1181121, 1924669, 2517925, 2550000, 3002806332, 3003150158, 3003561301, 3003750284, 3006190736, 3006224287, 3006440892, 3010455511, 3010939897, 3023443877
Owner Operator Numbers 2517925, 9051947
Locations Covered Apodaca Nuevo Leon, MX; BASINGSTOKE, HAMPSHIRE, GB; DARTFORD, KENT, GB; East Grinstead West Sussex, GB; Fremont, CA, US; HENNIGSDORF Brandenburg, DE; LENEXA, KS, US; MIDDLETOWN, VA, US; Oakwood Village, OH, US; PITTSBURGH, PA, US; ROSKILDE Sjalland, DK; Rochester, NY, US; Suzhou Jiangsu, CN; THEBARTON South Australia, AU; TIJUANA Baja California, MX

Registered Establishments (15)

Registration # Establishment Name Location Establishment Type(s) Action
1181121 Fisher Diagnostics MIDDLETOWN, VA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1314344 Nalge Nunc International Corporation Rochester, NY, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1530126 Remel Cleveland, A Division of Remel Inc. Oakwood Village, OH, US Develop Specifications But Do Not Manufacture At This Facility View Details
1924669 REMEL, INC. LENEXA, KS, US Manufacture Medical Device View Details
2517925 FISHER SCIENTIFIC COMPANY L.L.C. PITTSBURGH, PA, US Complaint File Establishment per 21 CFR 820.198 View Details
3003150158 NUNC A/S ROSKILDE Sjalland, DK Manufacture Medical Device View Details
3003561301 B.R.A.H.M.S GmbH HENNIGSDORF Brandenburg, DE Develop Specifications But Do Not Manufacture At This Facility View Details
3003750284 REMEL EUROPE LTD DARTFORD, KENT, GB Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3006190736 LABOMEX MBP TIJUANA Baja California, MX Manufacture Medical Device View Details
3006440892 OXOID AUSTRALIA PTY LIMITED THEBARTON South Australia, AU Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3010455511 Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd Suzhou Jiangsu, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3010939897 Microgenics Corporation Fremont, CA, US Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device View Details
3023443877 Thermo Fisher Scientific (Monterrey) Apodaca Nuevo Leon, MX Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
8010096 OXOID, LTD. BASINGSTOKE, HAMPSHIRE, GB Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device View Details
8021914 TREK DIAGNOSTIC SYSTEMS, LTD. East Grinstead West Sussex, GB Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0015-2008 Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic. Reason: Method is susceptible to positive interference from endogenous ALT in patient samples. 2007-07-24 Terminated View Details

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