Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006440892

FEI Number

3006440892

Entity Name

OXOID AUSTRALIA PTY LIMITED

City/State/Country

THEBARTON South Australia, AU

Establishment Address

20 DALGLEISH STREET, THEBARTON South Australia 5031, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,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

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GSH	Antisera, All Types, Listeria Monocytogenes	Microbiology	Class 1	866.3355	2007-05-04
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2007-05-04
LQM	Gram Negative Identification Panel	Microbiology	Class 1	866.2660	2011-12-19
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2007-05-04

Official Correspondent

No official correspondent registered.

US Agent Details

Rob Norris Business: REMEL INC Email: rob.norris@thermofisher.com Phone: (913) 4861246

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
1314344	Nalge Nunc International Corporation	Rochester, NY, US
3003150158	NUNC A/S	ROSKILDE Sjalland, DK

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
3004569406	BIOMERICA DE MEXICO, S.A. DE C.V.	MEXICALI Baja California, MX
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
8010096	OXOID, LTD.	BASINGSTOKE, HAMPSHIRE, GB
8010383	pro-lab incorporated	Richmond Hill Ontario, CA
3003750284	REMEL EUROPE LTD	DARTFORD, KENT, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006440892. Last updated year: 2026. Please use registration number 3006440892 when referencing this establishment in official correspondence.