Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010096

FEI Number

3006224287

Entity Name

OXOID, LTD.

City/State/Country

BASINGSTOKE, HAMPSHIRE, GB

Establishment Address

WADE RD., BASINGSTOKE, HAMPSHIRE RG24 8PW, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

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

K802502

PMA Number

N/A

All Registered Proprietary Names

ProSpecT Giardia Microplate assay R2458096 ProSpecT Giardia Microplate Assay Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 Sensititre GN Panel CT1960B Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test Discs Oxoid diagnostic discs Susceptibility Test Discs, Antimicrobial DrySpot E. coli Seroscreen Kit DrySpot E. coli 0157 Latex Test DrySpot Serocheck O128 Kit DrySpot Serocheck O145 Kit DrySpot Serocheck O111 Kit Escherichia ColiI O157 Latex Test DrySpot Serocheck O103 Kit DrySpot Serocheck O26 Kit DrySpot Serocheck O91 Kit S612130-2 IMAGEN RESPIRATORY SCREEN POS CON SLIDE K612011-2 IMAGEN Respiratory Screen Kit 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 R21370 TB Base Digestant R065270 Water R064450 Saline,0.85% (6ml) 100/PK R14503 Polysorbate 80(PS80), 02%(25ml) 100/PK R07140 Saline,0.85% R21256 Phosphate Buffer M/15 R09652 Phos Buffer,pH 7.2 (10ml) 100/PK R8325106 RapID Inoculation Fluid R21099 Sputagest 100 R21285 Oxalic Acid BTL/250ml R21076 NAC R064464 Saline,0.45% (3ml) 100/PK R20019 Bovine Albumin FractionV,0.2%(100ml)each R21079 NAC 100 R21368 TB Base Digestant R40181 Acridine Orange,Phenolic Decol R07302 Water (12.5ml) 20/PK R20182 Water (300ml) each R065272 Water R064462 Saline,0.45% (1.8ml) 100/PK R20018 Bovine Albumin FractionV,0.2%(50ml)each R21369 TB Base Digestant R21248 Phosphate Buffer M/15 BTL/ R21096 Sputagest 50 R21203 Brom Thymol Blue (1%) R210500 NAC Attack BTLx5/100ml R07141 Saline,0.85% R21195 Ammonium Hydroxide Concentrated R064430 Saline,0.85% (1ml) 100/PK R09971 Inoculum Water (25ml) 20/PK R064434 Saline,0.85% (2ml) 100/PK R064442 Saline,0.85% (4ml) 100/PK R21249 Phosphate Buffer M/15 R09651 Phos Buffer,Ph 7.2 (9ml) 100/PK R065262 Water R08432 Lactated Ringers R064448 Saline,0.85% (5ml) 20/PK R210250 NAC Attack R21236 Methyl Red Reagent R08194 Bovine Albumin FractionV,0.2%(10ml)20/PK R064446 Saline,0.85% (5ml) 100/PK R064438 Saline,0.85% (2.5ml) 100/PK R8325102 RapID Inoculation Fluid R064436 Saline,0.85% (2ml) 20/PK R064439 Saline (085%) 3mL R064490 Saline (0.85%) 3mL R112133 Buffered Peptone Water R112210 Demineralized Water 5mL ST8100 Oxoid (8 Places, 100 mm skirt) Antimicrobial Susceptibility Disc Dispenser Multiple T3339 DEMINERALIZED WATER (5ML) 100/pk R112433 Saline 0.85% R112211 Demineralized Water 5 mL R112111 Fluid A with Absorbic Acid ST1215 Oxoid (12 places, 150 mm skirt) Antimicrobial Susceptibility Disc Dispenser ST6100 Oxoid (6 Places, 100 mm skirt) Antimicrobial Susceptibility Disc Dispenser T3339-10 DEMINERALIZED WATER (5 mL) 10/PK ST6090 Oxoid (6 Places, 90 mm skirt) Antimicrobial Susceptibility Disc Dispenser T3491 Saline Tween w/ Glass Beads; 10/box MB1448A REAGENT SPOT INDOLE DMACA WILKINS CHALGREN ANAEROBE AGAR DR0704G PATHODXTRA STREP GROUP D LATEX DR0706G PATHODXTRA STREP GROUP G LATEX DR0587G Latex Grouping Reagent B DR0710M PATHODXTRA STREP GROUPING REAGENT SET DR0590G Latex Grouping Reagent F Streptococcal Grouping Reagent G Streptococcal Grouping Reagent D DR0588G Latex Grouping Reagent C Strep Plus Extraction Reagent Kit Streptococcal Grouping Kit DR0586G Latex Grouping Reagent A DR0709M PathoDxtra Extraction Reagents DrySpot Pneumo DR0700M PathoDxtra Strep Grouping Kit (60 tests) Strep Plus Kit DR0591G Latex Grouping Reagent G DR0705G PATHODXTRA STREP GROUP F LATEX Streptococcal Grouping Reagent B Polyvalent Positive Control DR0701G PATHODXTRA STREP GROUP A LATEX DR0500G Oxoid Reaction Cards Streptococcal Grouping Reagent F Streptococcal Grouping Reagent A DR0720G PATHODXTRA DISPOSABLE CARDS Streptococcal Grouping Reagent C DR0707G PathoDxtra Polyvalent Positive Control DR0702G PATHODXTRA STREP GROUP B LATEX DR0703G PATHODXTRA STREP GROUP C LATEX DR0589G Latex Grouping Reagent D Extraction Enzyme SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL R21215 Esculin Hydrolysis Reagent R21251 Potassium Hydroxide (KOH) 3% R21221 Hippurate Hydrolysis Reagent R21227 Indole Reagent,Kovac's R21213 Indole Reagent,Ehrlich's R21258 PYR Reagent R21281 VP-B (40% KOH) BTL/25ml R21254 Potassium Tellurite (0.2%) R21231 Potassium Hydroxide (KOH) 20% R21230 Potassium Hydroxide (KOH) 10% R21200 VP-A (alpha napthol 5%) R211347 E. coli Screen w/Kovacs R21239 Nitrate Reagent A R21206 Bile Solubility Reagent (10%) R21245 Spot Indole Reagent (DMACA) R21226 Gelatin Reagent (12.5%) R21218 Ferric Chloride-PDA (10%) R211348 Enterococcus/Grp A Strep Screen R21242 Nitrate Reagent B R21238 Ninhydrin Reagent R21233 Potassium Hydroxide (KOH) 20% w/glycerol RapID Staph Plus Panels M. Cat. Butyrate Disk Pathotec CO Gram-Sure Disk SPS Disk Micro-ID Listeria Identification System RapID Nitrate A Reagent RapID Nitrate B Reagent Oxichrome Reagent Legionella Kit Buffer RapID Spot Indole Reagent CT0998B BLANK DISCS DD0030S Oxoid Bacitracin Diagnostic Discs Oxoid V.C.N.T. SELECTIVE SUPPLEMENT Antisera, Fluorescent, All Types, Staphylococcus Spp. Clostridium Difficile YERSINIA SEL. AGAR BASE ProSpecT C.difficile A/B R244596 ProSpecT C. difficile Toxin A/B Microplate CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL Susceptibility Test Discs, Antimicrobial Sensititre GP Panel MB1561A Microbact Staph 12S MB1588A Microbact Staph Fast Blue Reagent CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH SAM20 AMPICILLIN / SULBACTAM IMAGEN Influenza Virus A and B kit VDRL Card Tiles VDRL Carbon Antigen VDRL Test Kits SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL IPM10 IMIPENEM Oxoid Antimicrobial Susceptibility Discs Thermo Scientific Oxoid Meropenem/VaborbactamDisc (30?g) MEV30 S610930-2 IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE IMAGEN Chlamydia Oxoid PSEUDOMONAS C-N SEL.SUPPL. 1 X 10 Oxoid selective supplement K610611-2 IMAGEN HSV Kit (50 tests) IMAGEN Herpes Simplex Virus kit SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL CT0149B Oxoid Cefaclor (30 µg) CEC30 Antimicrobial Susceptibility Test Discs SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL R2450030 Xpect Giardia Control R2450020 Xpect Giardia Xpect Giardia Xpect Giardia Control R01503 Haemophilus Test Medium (100mm) 10/PK R04033 Haemophilus Test Medium (150mm) 10/PK Haemophilus Test Medium CT1951B, Oxoid Lefamulin (20?g) LMU20 Antimicrobial Susceptibility Test Discs Susceptibility Test Discs, Antimicrobial SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL Culture Media, Selective And Differential Susceptibility Test Discs, Antimicrobial CEC30 CEFACLOR R01202 Blood Agar,5% Sheep Blood R01060 Anaer Reducible Blood Agar R08905 Trichophyton Agar #2 R01498 Blood Agar,Horse Bld w/Pyridoxal R07013 Blood Agar,5% Sheep Blood R09927 Trichophyton Agar #7 R08901 Trichophyton Agar #1 R10141 Rice Grain medium R01255 Brucella w/5% SB,Hem,Vit K R02460 Haemophilus ID Quad R01205 Blood Agar,Modified R01587 Mannitol Salt Agar R02192 Spectra UTI/Blood Agar Biplate R08921 Trichophyton Agar #6 R01210 Blood Agar,5% Rabbit Blood R01819 Spectra UTI R09919 Trichophyton Agar #5 R064850 Triple Sugar Iron Agar R01200 Blood Agar,5% Sheep Blood R09340 DNase Test Agar,Toluidine Blue R09400 Hypoxanthine R01375 DNase Test Agar R04012 Brucella w/Lkd Bld,Hem,Vit K(150mm) R09052 Aspergillus Differential R01376 DNase Test Agar,Methyl Green R060312 Blood Agar,5% Sheep Blood R09286 Cornmeal Agar w/1% Dextrose R01343 BCYE,Differential Agar w/BTB,BCP R04011 Brucella w/5% SB,Hem,Vit K R02029 Blood/Chocolate Biplate R08909 Trichophyton Agar #3 R064540 SIM Medium R02019 Blood/Blood Biplate R01212 Casman Agar w/5% Sheep Blood R01950 V Agar R02193 Spectra UTI/Blood Agar Biplate 100/PK R08925 Trichophyton Agar #7 R01214 Columbia Blood Agar w/3% SB R09923 Trichophyton Agar #6 R01099 Anaer Medium I R01540 LSM Agar R02030 Blood/Chocolate Biplate R08913 Trichophyton Agar #4 R01058 McClung Toabe w/o Neomycin R01252 Brucella Agar w/5% SB R01100 Anaer Medium II R064522 Sellers Agar R08056 BCP Milk Solids Glucose Agar R09960 Tyrosine Agar R01254 Brucella w/5% SB,Hem,Vit K R01209 Blood Agar,5% Sheep Blood R01818 Spectra UTI R01204 Blood Agar,10% Sheep Blood R02020 Blood/Blood Biplate R01253 Brucella Agar w/5% SB R01040 Anaer Blood Agar R01217 Columbia Blood Agar w/5% SB R09903 Trichophyton Agar #1 R01215 Columbia Blood Agar w/5% SB Multiple R21415 Yeast Extract (10%) BTL/10ml R450600 OADC Enrichment (2ml) PK/10 Multiple Oxoid diagnostic discs ATM30 AZTREONAM Kit, Anaerobic Identification OXOID PBP2 LATEX AGGLUTINATION TEST DRYSPOT E.COLI 0157 LATEX KIT Antisera, All Types, Escherichia Coli R2454096 ProSpecT Cryptosporidium Microplate Assay ProSpecT Cryptosporidium Microplate Assay (Mono) Susceptibility Test Discs, Antimicrobial Staphytect DrySpot Kit CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL Susceptibility Test Discs, Antimicrobial SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL NAFCILLIN 1ug Oxoid STREPTOCOCCUS SELECTIVE SUPPL.1X10 VIALS R2476096 ProSpecT Campylobacter Microplate Assay 96 Tests ProSpecT Campylobacter Microplate Assay CT0446B Ofloxacin Antimicrobial Susceptibility Disks Susceptibility Test Discs, Antimicrobial STAPHYLASE TEST Oxoid DERMASEL SELECTIVE SUPPLEMENT CT1975B Thermo Scientific Oxoid Gepotidacin Disc (10 ?g) GEP10 DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION Antisera, All Types, Escherichia Coli Susceptibility Test Discs, Antimicrobial Antisera, All Groups, Streptococcus Spp. Susceptibility Test Discs, Antimicrobial R01585 MRS Agar R01862 SXT Blood Agar R10067 Dermatophyte Test Medium R01236 Blood Agar w/Neomycin(60mcg) 10/PK R01564 MacConkey CT-Sorbitol 10/PK R02401 Avian Quad Plate R09542 MacConkey Agar R20203 A7 Agar w/Putrescine R01227 Blood Agar w/Gent(10mcg) R01328 Cornmeal Agar w/PS80 R01552 MacConkey Agar R02150 Cetrimide/Vogel John Biplate R09538 MacConkey w/o Crystal Violet R01231 Blood Agar w/Neomycin(10mcg) R01558 MacConkey w/o Crystal Violet R02180 Anaer CNA/Brucella LKV Biplate R09290 Cornmeal Agar w/PS80 R09680 RIOT Agar R01266 CCFA Modified Agar w/Horse Blood R02041 Blood/EMB,Levine Biplate R01865 TCBS Agar R20202 A7 Agar R01104 B Frag Isolation Agar R01405 EMB Agar,Modified R02092 MacConkey/Mannitol Salt Biplate R060302 Bile Esculin Azide Broth R01710 Pseudomonas F Agar R07102 EC Broth w/DT R01962 Vibrio Detection Agar R02066 Columbia CNA w/5% SB/Mac Biplate R01194 Bile Esculin Azide Agar R01299 CGB Agar R01550 MacConkey Agar R02144 Tergitol 7 w/TTC/Blood Biplate R01856 Strep A Isolation Agar R01583 Mannitol Salt Agar w/4ug Oxacillin R01861 SXT Blood Agar R09979 Yeast Ext Phosphate Agar R92207 SP4 Glucose Agar,Diphasic R01481 HE Agar (Hektoen Enteric) Agar R01616 Molybdate Agar R07089 Listeria Enrichment Broth R01190 Bile Esculin Agar R01269 CCFA-ST R02050 Blood/MacConkey Biplate R02136 Anaer Reduc LKV/Reduc Bld w/N,V R01191 Bile Esculin Agar R01180 BiGGY Agar,Nickerson R01282 Candida BCG Agar R02060 Columbia CNA w/5% SB/EMB Biplate R01441 Esculin Iron Agar R01590 McCarthy Agar R02140 Salmonella Shigella/XLD Biplate R20276 SP4 Glucose Agar R02126 Anaer Reduc LKV/PEA w/Vit K Biplate R061338 MacConkey Broth R01189 Bile Esculin Azide Agar R01268 CCFA Modified Agar R01480 HE Agar (Hektoen Enteric) R02049 Blood/MacConkey Biplate R02135 Anaer Reduc CNA/Reduc LKV Biplate R01615 Mitis Salivarius Agar R064582 Salmonella Shigella Agar R01053 Anaer LPV Blood Agar R01402 EMB Agar,Levine R01192 Birdseed Agar R01292 Cetrimide Selective Agar R01541 MRL Red Agar R02088 Anaer Reducible CNA/KBE Biplate R02063 Columbia Blood/MacConkey Biplate R02142 SXT Blood/SXT Blood Biplate R20376 SP4 Glucose Broth R01044 Anaer LKV Blood Agar R01365 Dermatophyte Test Medium R01982 XLD Agar R02077 Columbia CNA/EMB,Levine Biplate R01980 XLD Agar R02068 EMB Agar,Levine/MacConkey Biplate R01712 Pseudomonas Isolation Agar R01108 Baird Parker Agar R01243 Bovine Blood w/Esculin R01576 MacConkey w/Ceftazidime R01406 EMB Agar,Modified R02124 Anaer Reducible Bld/PEA w/SB,Vit K R060734 Cystine Tellurite Bld Agar R07910 Trich/Yeast Broth R01845 Staph 110 Medium R02006 Anaer Reduc LKV/B Frag(BBE)Biplate R01857 Strep Selective Agar R060292 Bile Esculin Agar R01245 B Cepacia Selective Agar R09832 TCBS Agar R20211 A7 Agar w/Phenol Red R01580 Mannitol Salt Agar R01860 SXT Blood Agar R09897 Tinsdale Agar Base R01056 McClung Toabe Agar R01403 EMB Agar,Levine R01228 Blood Agar w/Neomycin(30mcg) R02089 Anaer Reducible LKV/KBE Biplate R20433 Mycoplasma Broth III R01348 Cystine Tellurite Blood Agar R060294 Bile Esculin Agar R01247 Bril Green Agar w/Novobiocin R01557 MacConkey Agar R02176 CDC Blood/B Frag (BBE) Biplate R02040 Blood/EMB,Levine Biplate R01867 Strep Selective Agar R08462 Littman Oxgall Agar R09548 MacConkey w/Sorbitol R02065 Columbia CNA w/5% SB/Mac Biplate R20204 A8 Agar,Selective R01864 Strep Selective Agar R20201 A7 Agar R01045 Anaer LKV Blood Agar R01246 Bril Green Agar R01855 Strep A Isolation Agar R01400 EMB Agar,Levine R02010 Bile Esculin/BHI w/6.5%NaCl Biplate R02086 HE (Hektoen Enteric)/XLD Biplate R01840 Salmonella Shigella Agar R01998 Yersinia Sel (CIN) Agar R01483 HE Agar (Hektoen Enteric) R01709 Burkholderia Cepacia Agar R07100 EC Broth w/DT R01806 Schaedler LKV Agar R01983 XLD Agar w/20mg/L Novo R08352 Dermatophyte Test Medium CM0007B MACCONKEY AGAR, CM0617B Bacillus cereus Selective Agar Base (PEMBA) CM0227B Desoxycholate Citrate Agar (Hynes) Multiple Spectra Candida Agar R01833 CT1971B Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 ?g) AZA50 R060286 BHI Broth w/6.5% NaCl R20806 Tetrathionate Broth R062582 Phos Buffered Saline R060992 GN Broth R064508 Selenite Broth w/Cystine R060988 GN Broth R08380 GN Broth R064503 Selenite Broth R07160 Tetrathionate Broth R064844 Todd Hewitt Brothw/Gent,NA,SB R060990 GN Broth R064506 Selenite Broth w/Cystine R064840 Todd Hewitt Broth w/Gent,NA R07162 Tetrathionate Broth R062620 Potassium Chloride Solution(4.5ml) R064842 Todd Hewitt Broth w/Gent,NA R060936 Fletchers Med w/o 5% Fluorauracil R07161 Tetrathionate Broth w/BG R07754 Nutrient Broth,7% NaCl R08382 GN Broth R060284 BHI Broth w/6.5% NaCl CM0009B PEPTONE WATER, CM0733B Maximum Recovery Diluent CM0699B SELENITE CYST.BROTH BASE IMAGEN PARAINFLUENZA GROUP IMAGEN Parainfluenza Virus Group kit K610311-2 IMAGEN PARAINFLUENZA VIRUS TYPES 1, 2, 3 Susceptibility Test Discs, Antimicrobial SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL Susceptibility Test Discs, Antimicrobial ProSpecT Giardia/Cryptosporidium Microplate Assay R2458496 ProSpecT Giardia/Cryptosporidium Microplate Assay 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 Antisera, Fluorescent, All Types, Staphylococcus Spp. RD5 RIFAMPICIN SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL Prospect E. Histolytica R2456096 ProSpecT Entamoeba histolytica Microplate Assay 96 Tests Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 S S AGAR Susceptibility Test Discs, Antimicrobial Oxoid CAMPYLOBACTER SEL.SUPP.(BLASER-WANG)1X10 VIALS WILKINS CHALGREN ANAEROBE BROTH R01662 PEA w/5% Sheep Blood R10105 LJ Mycobactocel R01148 BHI w/SB,CGC R01542 MRL Green Agar R01630 Mycobiotic Agar (Mycocel) R10048 BHI w/SB,CGC R01507 Inhibitory Mold Agar R08576 Mitchison 7H11 Selective R01509 Inhibitory Mold Agar w/Cipro,Vanc R08602 Mycobiotic Agar (Mycocel) R10044 BHI Agar w/SB,Chlor,Gent R01470 Haemophilus Isolation w/Bacitracin R08520 LJ Gruft R01261 Brucella Agar w/Horse Blood,TVP R01333 BCYE w/BTB, BCP & PAV R01356 CNA w/SB,Col,NA,Amp B,Gent,Vanc R01063 Anaer Reducible CNA Bld Agar R08410 Inhibitory Mold Agar R01954 VACC Agar R061336 MacConkey Broth R08724 Sab Dex Agar,Emmons w/Chlor R01704 Potato Flake Agar w/Cipro,Vanc R060274 BHI Broth w/1ug Ciproflo 5ml 20/PK R241055 Mycobiotic Agar (MycoTube) R20260 PPLO Agar R01754 SABHI Agar w/Chlor,Cyclo R08072 BHI Agar w/SB,Chlor,Gent (slant) 20/PK R08816 TCH Agar,5mcg/ml R01506 Inhibitory Mold Agar w/Gent R08574 Mitchison 7H11 Selective R09322 Czapek Medium R01660 PEA w/5% Sheep Blood R10102 LJ Gruft R01049 Anaer PEA Blood Agar R01610 Mitchison 7H11 Selective R01733 Rose Agar R08742 Sab Dex,Emmons w/Chlor,Gent R10158 Sab Dex Agar,Emmons w/Chlor R01502 Inhibitory Mold Agar w/Gent(26ml) 100/PK R07020 Bril Green Bile Broth,2% w/DT R01043 Anaer KV Blood Agar R01600 Middlebrook 7H10 Agar R08734 Sab Dex,Emmons w/Cyclo R01317 Chocolate w/Vanc,Serum (Nairobi) R01478 HBT Bilayer Medium R08522 LJ Gruft R01048 Anaer PEA Blood Agar R01608 Middlebrook 7H11 Agar w/Myco J R08738 Sab Dex Agar,Emmons w/Gent R10155 Sab Dex Agar,pH 5.6 R01543 MRL Yellow Agar R08215 CEA Agar w/CGC R08699 SABHI w/Sheep Blood,Chlor R01505 Inhibitory Mold Agar R08532 LJ Mycobactocel R09300 BCYE Agar (22ml deep) 20/PK R08080 BHI w/SB,CGC (slant) 20/PK R01274 Campy Selective Medium R01341 BCYE w/PAV R02112 Middlebrook 7H11/Mitchison7H11 Sel R08078 BHI w/SB,CGC (slant) 100/PK R01575 Catarrhalis Selective Medium R08726 Sab Dex Agar,Emmons w/Chlor R241067 Sab Dex Emmons w/Chlor,Gent R01123 BHI Agar w/SB,Chlor,Gent R01279 Campy Chocolate w/TVAP R01769 Sab Dex, Emmons w/Chlor R01144 BHI Agar w/SB,Chlor,Gent R01294 Charcoal Selective Medium R01776 Sab Dex Agar,Emmons w/Gent R064844 Todd Hewitt Brothw/Gent,NA,SB R01160 BHI w/SB,Pen,Strep,Yst Ext R01646 Mycobiotic Agar (Mycocel) R10070 Inhibitory Mold Agar R01168 BHI Agar w/Fildes,Bacitracin R10082 Jones Kendrick Transport R01350 Czapek Medium Plate R08298 Cottonseed Agar R08703 SABHI Agar w/Sheep Bld,Gent R01304 Chocolate Agar w/Bacitracin R01508 Inhibitory Mold Agar R08600 Mycobiotic Agar R01338 BCYE w/DGVP R01258 Brucella w/5% SB,TVP (Skirrow) R01703 Potato Flake Agar w/Chlor,Cyclo R07022 Bril Green Bile Broth,2% w/DT R10130 Mycobiotic Agar R08068 BHI Agar w/Chlor,Cyclo (slant) 100/PK R01298 Charcoal Bld Agar (Regan Lowe) R01790 Sab Dex,pH 5.6 w/Chlor R01346 Cystine Heart Agar R08070 BHI Agar w/SB,Chlor,Gent R08608 Mycological Agar R01142 BHI Agar w/SB,Chlor,Cyclo R01772 Sab Dex,Emmons w/Chlor,Gent R01050 Anaer PV Blood Agar R01612 Mitchison 7H11 Selective 16/PK R01740 Rogosa Agar R08812 TCH Agar,1mcg/ml R110131 Cetrimide Selective Agar 100/PK R01140 BHI Agar w/SB,Chlor R01771 Sab Dex,Emmons w/Chlor,Cyclo R01812 Spectra Strep A agar Multiple R111030 Contact I Mycological w/Lec,PS80 20/PK CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL Staphytect Plus Staphytect Plus Tests Latex Staphytect Plus Control Latex Oxoid VITOX SUPP+REHYDRATION FLUID 2X5VIALS Multiple R2450001 ProSpecT Wash Buffer Susceptibility Test Discs, Antimicrobial Oxoid Mycoplasma Supplement ZOX30 CEFTIZOXIME Oxoid diagnostic discs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2009-10-16
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2022-09-29
LQM	Gram Negative Identification Panel	Microbiology	Class 1	866.2660	2011-12-19
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2024-10-25
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2015-08-25
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2005-11-08
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2024-06-17
KZJ	Device, Gas Generating	Microbiology	Class 1	866.2580	2015-08-25
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2007-05-04
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	1998-02-24
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2016-07-04
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2002-02-27
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2005-05-31
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2015-08-25
GTN	Antisera, Fluorescent, All Types, Staphylococcus Spp.	Microbiology	Class 1	866.3700	2015-08-04
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	2016-07-04
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	2016-07-04
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2009-10-16
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	2015-08-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
LQL	Gram Positive Identification Panel	Microbiology	Class 1	866.2660	2011-12-19
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	Class 2	866.1700	2015-08-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2016-06-22
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2007-06-26
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2009-10-16
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2016-06-22
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-25
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2019-01-28
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	Microbiology	Class 1	866.3120	2007-06-26
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	2015-08-25
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2015-08-25
GQN	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2007-06-26
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2024-07-03
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2009-12-01
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2008-12-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2024-09-27
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2015-08-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2016-07-04
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	1978-06-21
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	1978-06-21
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2015-08-25
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2016-07-04
JSP	Kit, Anaerobic Identification	Microbiology	Class 1	866.2660	2015-08-04
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2015-08-25
MYI	System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies	Microbiology	Class 2	866.1640	2005-11-08
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2013-01-03
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2015-08-04
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2009-10-16
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2005-02-24
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2015-08-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2015-08-25
LQP	Campylobacter Spp.	Microbiology	Class 1	866.3110	2005-10-12
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2016-06-27
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
LHT	Staphylococcus Aureus Somatic Antigens	Microbiology	Class 1	866.3700	2005-11-08
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2015-08-25
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2026-01-20
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2015-08-05
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2015-08-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2015-08-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	1978-06-21
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2025-12-05
JSD	Culture Media, Selective Broth	Microbiology	Class 1	866.2360	1978-06-21
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2007-06-26
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2009-10-16
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2009-10-16
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2005-11-10
GTN	Antisera, Fluorescent, All Types, Staphylococcus Spp.	Microbiology	Class 1	866.3700	2015-08-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	2009-10-16
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2022-09-30
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2016-07-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2015-08-25
JSC	Culture Media, General Nutrient Broth	Microbiology	Class 1	866.2350	2016-07-04
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	1978-06-21
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2015-08-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-04
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2009-10-16
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2015-08-25
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2007-05-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2015-08-05
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2015-08-25
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2016-07-04
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2015-08-25

Official Correspondent

No official correspondent registered.

US Agent Details

Joel Mathew Business: Remel, Inc Email: joel.mathew@thermofisher.com Phone: (913) 9540078

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
K930451	Alexon, Inc.	PROSPEC T GIARDIA MICROTITER ASSAY	1993-04-21
K002664	Hardy Diagnostics	HARDYDISK LEVOFLOXACIN, 5MCG	2000-10-26
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17
K863524	Bd Becton Dickinson Vacutainer Systems Preanalytic	REGAN-LOWE CHARCOAL AGAR	1986-09-19
K812581	Uti-Tect, Inc.	SENSI-TECT	1981-09-23

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-0011-2008	Pml Microbiologicals Inc.	2	Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
Z-0014-2008	Pml Microbiologicals Inc.	2	Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
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
2013736	MEDICAL CHEMICAL CORPORATION	TORRANCE, CA, US
2029372	Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, US
3003750284	REMEL EUROPE LTD	DARTFORD, KENT, GB
1924669	REMEL, INC.	LENEXA, KS, US
1122855	TECHLAB, INC.	BLACKSBURG, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010096. Last updated year: 2026. Please use registration number 8010096 when referencing this establishment in official correspondence.