Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003750284

FEI Number

3003750284

Entity Name

REMEL EUROPE LTD

City/State/Country

DARTFORD, KENT, GB

Establishment Address

REMEL HOUSE, CLIPPER BLVD., WEST CROSSWAYS, DARTFORD, KENT DA2 6PT, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Thermo Fisher Scientific (Owner Number: 2517925)

Owner / Operator Contact Address

168 Third Avenue, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kanamycin Disk N meningitidis Group W135 Agglutinating Sera BactiStaph Latex IMAGEN Respiratory Syncytial Virus kit K610211-2 IMAGEN Respiratory Syncytial Virus (RSV) Vancomycin Disk Micro-ID Microbial Identification System Remel D-Dimer Streptex Rapid Streptex Acid Extraction Kit Streptex Latex Group A Streptex Latex Group C Streptex Latex Group G Streptex Latex Group F Streptex Extraction Enzyme Streptex Kit Streptex Polyvalent Positive Control Streptex Latex Group B Streptex Latex Group D Sensititre 18-24 hour MIC or Breakpoint Susceptibility System CMC1OUPF CMC6AFLF CMC7AFLF Sensititre® 18 -24 hour MIC or Breakpoint Susceptibility System" with Minocycline Hippurate Disk Colistin Disk IMAGEN Influenza Virus A and B kit CMC1GPUF Susceptibility Test Panel for Vancomycin VRSA 1-128jg/ml Brucella abortus Stained Suspension Brucella melitensis Stained Suspension Prospect Giardia EZ H influenzae type f Agglutinating Sera H influenzae type d Agglutinating Sera H influenzae type c Agglutinating Sera H influenzae type e Agglutinating Sera H influenzae type b Agglutinating Sera H influenzae type a Agglutinating Sera OXOID PBP2 LATEX AGGLUTINATION TEST Wellcolex E.coli O157:H7 Niacin Control Disk E.COLI 0157 ELISA S E. COLI 0157 ELISA PYR Disk Test PYR Disk w/Reagent Wellcogen N meninigitidis A,C,Y, W135 ProSpecT Shiga Toxin E. coli Microplate Assay PRO Disk w/Reagent M. pneumoniae IgG/IgM Antibody Salmonella H z Agglutinating Sera Salmonella H 1,6 Agglutinating Sera Salmonella H b Agglutinating Sera Salmonella H 1,7 Agglutinating Sera Salmonella O Factor 13, 22 (Group G) Agglutinating Sera Salmonella H f,g Agglutinating Sera Salmonella H z6 Agglutinating Sera Salmonella H z4, z23 Agglutinating Sera Salmonella H e,n,x Agglutinating Sera Salmonella O Factors 3,10,15, 19 (Group E) Agglutinating Sera Salmonella O Factor 18 (Group K) Agglutinating Sera Salmonella H enz15 Agglutinating Sera Salmonella O Factor 28 (Group M) Agglutinating Sera Salmonella H e,h Agglutinating Sera Salmonella H l,w Agglutinating Sera Salmonella H g,p Agglutinating Sera Salmonella O Factor 17 (Group J) Agglutinating Sera Salmonella H z36 Agglutinating Sera Salmonella O Factor 8 (Group C2) Agglutinating Sera Salmonella H y Agglutinating Sera Salmonella H i Agglutinating Sera Salmonella H G Polyvalent Agglutinating Sera Salmonella H m,t Agglutinating Sera Salmonella H d Agglutinating Sera Salmonella O Factor 10 (Group E1) Agglutinating Sera Salmonella H Polyvalent Phases 1 & 2 Agglutinating Sera Salmonella O Factor 14 (Group H) Agglutinating Sera Salmonella O Factor 15 (Group E2) Agglutinating Sera Salmonella O Polyvalent (Groups A to G) Agglutinating Sera Salmonella H a Agglutinating Sera Salmonella H Rapid Diagnostic 2 Agglutinating Sera Salmonella Vi Agglutinating Sera Salmonella H z38 Agglutinating Sera Salmonella H Polyvalent Phase 2 Agglutinating Sera Salmonella O Factor 39 (Group Q) Agglutinating Sera Salmonella H l,v Agglutinating Sera Salmonella O Factor 2 (Group A) Agglutinating Sera Salmonella O Factor 20 (Group C2) Agglutinating Sera Salmonella H r Agglutinating Sera Salmonella H c Agglutinating Sera Salmonella O Factor 38 (Group P) Agglutinating Sera Salmonella O Factor 21 (Group L) Agglutinating Sera Salmonella O Factor 4 (Group B ) Agglutinating Sera Salmonella H L Polyvalent Agglutinating Sera Salmonella H z29 Agglutinating Sera Salmonella H Rapid Diagnostic 1 Agglutinatingl Sera Salmonella O Factor 19 (Group E4) Agglutinating Sera Salmonella H Rapid Diagnostic 3 Agglutinating Sera Salmonella H g,q Agglutinating Sera Salmonella O Factor 5 (Group B) Agglutinating Sera Salmonella H z27 Agglutinating Sera Salmonella O Factor 27 (Group B) Agglutinating Sera Salmonella H k Agglutinating Sera Salmonella H 1,5 Agglutinating Sera Salmonella O Factor 41 (Group S) Agglutinating Sera Salmonella O Factor 6,7 (Group C1) Agglutinating Sera Salmonella H z10 Agglutinating Sera Salmonella O Factor 16 (Group I) Agglutinating Sera Salmonella H E Polyvalent Agglutinating Sera Salmonella O Factor 30 (Group N) Agglutinating Sera Salmonella O Factor 11 (Group F) Agglutinating Sera Salmonella O Polyvalent (Groups A to S) Agglutinating Sera Salmonella H g,s,t Agglutinating Sera Salmonella O Factor 9 (Group D) Agglutinating Sera Salmonella O Factor 40 (Group R) Agglutinating Sera Salmonella H 1,2 Agglutinating Sera Salmonella H g,m Agglutinating Sera Salmonella O Factor 35 (Group O) Agglutinating Sera Nitrate Swab Wellcogen Streptococcus pneumoniae DRYSPOT E.COLI 0157 LATEX KIT Xpect Flu A&B Control RapID NH System Prospect E. Histolytica R2456096 ProSpecT Entamoeba histolytica Microplate Assay 96 Tests N Meningitidis Staphytect DrySpot Kit PathoDx Herpes Haemophilus Identification Kit PathoDX Chlamydia Trachomatis FA Direct Test Kit PYR/Esculin Disk R2454096 ProSpecT Cryptosporidium Microplate Assay ProSpecT Cryptosporidium Microplate Assay (Mono) Wellcolex E.coli O157 RapID CB Plus System Multiple Accessories 95% Dehydrant Isopropanol R40132 Ethanol (95%) 70% Dehydrant R40106 TB Decolorizer (Acid Alcohol) 3% R2470110 Ethanol (70%) Methanol Flex 95 Cell Wash Solution I/NaOH-D 60% Dehydrant CleanCell M 2x2L, Para-Release Spray Isopropyl Alcohol Flex 100 100% Dehydrant R40206 TB Decolorizer (3%) R40134 Acid Ethanol (90%), Methyl Alcohol Flex 80 Acetone Base Mold Release Syntri Safeguard, Flex 100 Fast Flex Kit 1 Ethyl Alcohol 80% Dehydrant Cell Wash Solution I/NaOH-D 2x1, 8L Syntri Safeguard, Isopropyl Alcohol Fast Flex Kit 2 Reagent Alcohol Syntri Safeguard, Dehydrant 100% Clean Cell M 2x2L HE600 Cleaning Kit Thrombo-Wellcotest STP8F Sensititre Haemophilus influenza/Streptococcus pneumoniae MIC Susceptibility Plate Urea-PDA Disk IMAGEN CHLAMYDIA SPECIMEN COLLN Wellcolex Colour Shigella Wellcolex Colour Salmonella VDRL Card Tiles VDRL Carbon Antigen VDRL Test Kits Niacin Reagent Strip R2451030 Xpect Cryptosporidium Control Cryptosporidium Spp. Candida albicans Disk C. Albicans disk ProSpecT Giardia/Cryptosporidium Microplate Assay R2458496 ProSpecT Giardia/Cryptosporidium Microplate Assay Streptex Acid Extraction Kit Proteus OX19 Agglutinating Sera Proteus OXK Agglutinating Sera Proteus OX2 Agglutinating Sera Sensititre 18-24 hours Susceptibility Plates (OMADACYCLINE) OMADFAST R2476096 ProSpecT Campylobacter Microplate Assay 96 Tests ProSpecT Campylobacter Microplate Assay N meningitidis B monoclonal antibody SENSITITRE SUSCEPTIBILITY PLATES (DORIPENEM) CMC1MDNF ProSpecT Giardia Microplate assay R2458096 ProSpecT Giardia Microplate Assay R30851502 Protease Tablet R30851501 Cryptococcus LTX Antigen Test 50TST/KT Cryptococcus Latex Antigen Test A.L.A. Disk R242007 PROSPECT GIARDIA PAB 1MG R242028 PROSPECT GIARDIA MAB 1MG GIARDIA SPP. MUTIPLE Staphaurex Plus Bordetella pertussis Agglutinating Sera Nitrocefin Disk RapID ONE System Thymune M PathoDX Chlamydia Culture Confirmation Kit Febrile Positive Control Febrile Negative Control Legionella Pneumophilia 1 Legionella Species Tests Kit DrySpot Legionella Pneumo.Serogroup 2-14 Legionella Latex Agglut. Tests Kit Legion. Pneumophilia Reag. Kit DrySpot Legionella Species Legion. Pneumophilia 2-14 Kit PathoDX Extraction Reagent 3 PathoDX Strep A Hospital Kit PathoDX Control Latex PathoDX Extraction Reagent 1 PathoDX Strep A Latex PathoDX Strep C Negative Control Swab PathoDX Strep A Positive Control Swab PathoDX Extraction Reagent 2 Phytohaemagglutinin Purified Phytohaemagglutinin Reagent Grade MUG Disk Color Slide II Mononucleosis Test Novobiocin Disk ALN Disk w/Reagent PathoDX Strep F Grouping Latex PathoDX Strep G Grouping Latex PathoDX Disposable Slides PathoDX Control Antigen A, B, C PathoDX Strep Grouping Universal Kit bulk PathoDX Strep C Grouping Latex PathoDX Strep B Grouping Latex PathoDX Strep Grouping Kit PathoDX Control Antigen F, G PathoDX Strep Grouping Universal Kit PathoDX Strep A Grouping Latex RIM E.coli O157:H7 Latex PathoDX Influenza B Reagent PathoDX Parainfluenza 3 Reagent PathoDX Influenza A Reagent PathoDX RVP Control PathoDX Respiratory Viral Panel PathoDX Adenovirus Reagent PathoDX RVP Negative Control Reagent PathoDX Parainfluenza 1 Reagent PathoDX RVP Screen Reagent PathoDX Parainfluenza 2 Reagent PathoDX Respiratory Mounting Fluid PathoDX RSV Screening Reagent Neisseria Enzyme Test (NET) NET HPB2 Sensititre H. influenzae/Strep pneumoniae MIC or BP Susceptibility System with Ceftolozane-tazobactam 03/4-64/4ug/ml IDEIA PCE Chlamydia kit K610611-2 IMAGEN HSV Kit (50 tests) IMAGEN Herpes Simplex Virus kit Bacticard Neisseria SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (DOXYCYCLINE) CMC4VGPF CMC1AXPF S typhi Vi Stained Suspension S paratyphi a-H Stained Suspension S typhi d-H Stained suspension S non-sp. (1,2,5) Stained Suspension S paratyphi C-O (6,7) Stained Suspension S paratyphi b-H Stained Suspension S enteritidis H (g, m) Stained Suspension S typhi O (Group D) (9,12) Stained Suspension S paratyphi A-O (1,2,12) Stained Suspension S newport H sp (e, h) Stained Suspension S typhimurium H sp (i) Stained Suspension S paratyphi B-O (1,4,5,12) Stained Suspension S paratyphi C-H Stained Suspensions RapID Yeast Plus System R8323600 ERIC (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM) Staphytect Plus Staphytect Plus Tests Latex Staphytect Plus Control Latex Chlamydia Collection Kit Nitrate Disk Wellcogen H Influenzae B IMAGEN RVP PathoDx RSV CMC5VGPF CMC6VGNF SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (CEFTAZIMDIME/AVIBACTAM) CMC5VGNF ProSpecT C.difficile A/B R244596 ProSpecT C. difficile Toxin A/B Microplate S610930-2 IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE IMAGEN Chlamydia Prospect Giardia Controls CMC1OUNF Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam durlobactam in dil range 015/4-32/4 µg/mL ARUP1MDF MDRGN4F Bacticard E.coli Multiple SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES - STREPTOMYCIN CMC1GPVF ProSpecT Rotavirus IDEIA PCE Chlamydia Blocking Reagent kit Pyridoxal Disk LAP Disk MEROVAB Sensititre 18-24 hour MIC or BP Susceptibility System with Meropenem/Vaborbactam (008/8-18/8 ug/mL) STAPHYLASE TEST Catarrhalis Test Disk Indoxyl Acetate Disk LAP Disk w/Reagent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
GTJ	Antisera, All Groups, N. Meningitidis	Microbiology	Class 2	866.3390	2009-10-16
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2012-11-14
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2007-06-26
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
JSS	Kit, Identification, Enterobacteriaceae	Microbiology	Class 1	866.2660	2012-11-14
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2012-12-20
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2009-10-16
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2015-11-18
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2015-11-18
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2015-11-18
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2015-11-18
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2024-07-24
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2024-07-24
JTC	Device, Microtiter Diluting/Dispensing	Microbiology	Class 1	866.2500	2012-11-14
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2007-06-26
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2024-07-24
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2024-07-24
GSO	Antigens (Febrile), Agglutination, Brucella Spp.	Microbiology	Class 2	866.3085	2003-01-22
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2009-10-16
GRP	Antisera, All Types, H. Influenza	Microbiology	Class 2	866.3300	2003-01-22
MYI	System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies	Microbiology	Class 2	866.1640	2005-11-08
GMZ	Antigens, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2009-10-16
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
GMZ	Antigens, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2005-10-12
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
GTJ	Antisera, All Groups, N. Meningitidis	Microbiology	Class 2	866.3390	2009-10-16
GMZ	Antigens, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2009-10-16
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2012-11-14
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2007-05-04
JXB	Kit, Identification, Yeast	Microbiology	Class 1	866.2660	2012-11-14
GWC	Antisera, All Types, Streptococcus Pneumoniae	Microbiology	Class 1	866.3740	2009-10-16
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2013-01-03
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2012-11-19
JSX	Kit, Identification, Neisseria Gonorrhoeae	Microbiology	Class 1	866.2660	2012-11-14
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	2009-10-16
GTJ	Antisera, All Groups, N. Meningitidis	Microbiology	Class 2	866.3390	2009-10-16
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2005-02-24
GQL	Antisera, Fluorescent, Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2009-10-16
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	Microbiology	Class 1	866.3120	2009-10-16
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2009-10-16
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2009-10-16
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2005-02-24
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2009-10-16
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2022-06-09
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2022-06-09
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2022-06-09
JSS	Kit, Identification, Enterobacteriaceae	Microbiology	Class 1	866.2660	2012-11-14
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2010-01-05
GNB	Antisera, All Types, Shigella Spp.	Microbiology	Class 2	866.3660	2009-10-16
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2009-10-16
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2009-10-16
MJD	Culture Media, Antimycobacteria, Susceptibility Test	Microbiology	Class 2	866.1700	2012-11-14
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2005-10-27
JXC	Kit, Screening, Yeast	Microbiology	Class 1	866.2660	2012-11-14
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2009-10-16
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2009-10-16
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2009-10-16
GSY	Antisera, Fluorescent, All Globulins, Proteus Spp.	Microbiology	Class 1	866.3410	2003-01-22
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-07-08
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2019-07-08
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-07-08
LQP	Campylobacter Spp.	Microbiology	Class 1	866.3110	2005-10-12
GTJ	Antisera, All Groups, N. Meningitidis	Microbiology	Class 2	866.3390	2009-10-16
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2016-08-12
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2009-10-16
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	2012-11-14
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2005-10-27
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2009-10-16
GOY	Antisera, Agglutinating, B. Pertussis, All	Microbiology	Class 1	866.3065	2003-01-22
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
JSS	Kit, Identification, Enterobacteriaceae	Microbiology	Class 1	866.2660	2012-11-14
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2009-10-16
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	Microbiology	Class 1	866.3120	2009-10-16
GSN	Antiserum, Positive And Negative Febrile Antigen Control Serum	Microbiology	Class 2	866.3085	2003-01-22
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2005-11-10
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2009-10-16
IBB	Phytohemaglutinin M	Pathology	Class 1	864.4010	2003-01-22
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2008-03-11
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2009-10-16
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2012-11-14
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2009-10-16
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2009-10-16
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Microbiology	Class 1	866.3480	2009-10-16
GNY	Antisera, Fluorescent, Adenovirus 1-33	Microbiology	Class 1	866.3020	2009-10-16
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2024-06-05
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2024-06-05
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2024-06-05
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Microbiology	Class 1	866.3120	2007-06-26
GQN	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2007-06-26
JSX	Kit, Identification, Neisseria Gonorrhoeae	Microbiology	Class 1	866.2660	2012-11-14
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2016-08-12
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2016-08-12
GNC	Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2003-01-22
JXB	Kit, Identification, Yeast	Microbiology	Class 1	866.2660	2012-11-14
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2009-10-16
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2007-06-26
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
GRD	Antiserum, Hai, Mumps Virus	Microbiology	Class 1	866.3380	2009-10-16
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Microbiology	Class 1	866.3480	2003-07-30
GNY	Antisera, Fluorescent, Adenovirus 1-33	Microbiology	Class 1	866.3020	2003-07-30
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2003-07-30
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Microbiology	Class 1	866.3480	2009-10-16
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2016-08-12
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2016-08-12
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2016-08-12
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2009-10-16
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	Microbiology	Class 1	866.3120	2007-06-26
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2009-10-16
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2023-12-10
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2002-02-27
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2016-08-11
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	Microbiology	Class 1	866.3405	2003-07-30
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Microbiology	Class 1	866.3120	2007-06-26
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2023-09-22
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-09-22
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2023-09-22
LHT	Staphylococcus Aureus Somatic Antigens	Microbiology	Class 1	866.3700	2005-11-08
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2012-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

Joel Mathew Business: Remel, Inc. Email: joel.mathew@thermofisher.com Phone: (913) 8954063

Related Public Records

Same Entity

Thermo Fisher Scientific

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010455511	Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd	Suzhou Jiangsu, CN
3006190736	LABOMEX MBP	TIJUANA Baja California, MX
2517925	FISHER SCIENTIFIC COMPANY L.L.C.	PITTSBURGH, PA, US
3006440892	OXOID AUSTRALIA PTY LIMITED	THEBARTON South Australia, AU
1314344	Nalge Nunc International Corporation	Rochester, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17
K760790	General Diagnostics	MICRO-ID	1976-10-29
K151534	Instrumentation Laboratory CO	HemosIL D-Dimer HS	2015-07-06
K160885	Instrumentation Laboratory CO	HemosIL D-Dimer HS	2016-10-27
K944753	Radiometer America, Inc.	SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP	1995-02-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2008	Thermo Fisher Scientific	1	Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Z-0015-2014	Sekisui Diagnostics LLC	1	Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

Similar Registrations

Registration Number	Establishment Name	Location
8010096	OXOID, LTD.	BASINGSTOKE, HAMPSHIRE, GB
1924669	REMEL, INC.	LENEXA, KS, US
3009307598	BIOMERIEUX SPAIN	Tres Cantos Madrid (Province), ES
3013160357	RR Donnelley Global Turnkey Solutions	Juarez Chihuahua, MX
2916932	ANAEROBE SYSTEMS	MORGAN HILL, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003750284. Last updated year: 2026. Please use registration number 3003750284 when referencing this establishment in official correspondence.