FDA Registration
Active
🇦🇺 Australia
OXOID AUSTRALIA PTY LIMITED
Reg #: 3006440892
·
FEI: 3006440892
·
Expires 2026
Products
7
Proprietary Names
168
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- OXOID AUSTRALIA PTY LIMITED
- Registration Number
- 3006440892
- FEI Number
- 3006440892
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 20 DALGLEISH STREET
- City
- THEBARTON South Australia
- Country
- AU
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
US Agent
- Business Name
- REMEL INC
- Contact Name
- Rob Norris
- Address
- 12076 SANTA FE DRIVE
- City
- LENEXA
- State
- KS
- ZIP
- 66215
- Country
- US
- [email protected]
- Phone
- 913 4861246
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antisera, All Types, Listeria Monocytogenes | GSH | Class 1 | Microbiology | No | 2007-05-04 |
| Antisera, All Groups, Salmonella Spp. | GRM | Class 2 | Microbiology | No | 2007-05-04 |
| Gram Negative Identification Panel | LQM | Class 1 | Microbiology | No | 2011-12-19 |
| Reagents, Clostridium Difficile Toxin | LLH | Class 1 | Microbiology | No | 2007-05-04 |
| Discs, Strips And Reagents, Microorganism Differentiation | JTO | Class 1 | Microbiology | No | 2005-05-31 |
| Gram Positive Identification Panel | LQL | Class 1 | Microbiology | No | 2011-12-19 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 1998-02-24 |
Proprietary Names
MULTIPLE LISTERIA TEST KITS
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
Sensititre GN Panel
Multiple
R2450001 ProSpecT Wash Buffer
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
Sensititre GP Panel
MB1561A Microbact Staph 12S
MB1588A Microbact Staph Fast Blue Reagent
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
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
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)