Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005269352

FEI Number

3005269352

Entity Name

Invetech Pty Ltd

City/State/Country

Mount Waverley Victoria, AU

Establishment Address

495 Blackburn Road, Mount Waverley Victoria 3149, AU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Invetech Pty Ltd (Owner Number: 10091241)

Owner / Operator Contact Address

495 Blackburn Road, Mount Waverley, AU-VIC 3149, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BIOPLEX 2200 Instrument TEG 6s MeMed BV TEG 6s

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2024-07-31
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2024-07-31
QPS	Immunoassay For Host Biomarkers Of Infection	Microbiology	Class 2	866.3215	2025-05-15
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2024-07-31
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2024-07-31

Official Correspondent

Aisling McGowan

US Agent Details

Paul Tsironis Email: Paul.Tsironis@invetech.us Phone: (858) 7683209

Related Public Records

Same Entity

Invetech Pty Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
K021022	Instrumentation Laboratory CO	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	2002-05-14
K113211	Instrumentation Laboratory CO	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	2012-01-04
K082859	Instrumentation Laboratory CO	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	2008-12-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04	Instrumentation Laboratory Co.	2	ACL Futura Instrument Analyzer

Similar Registrations

Registration Number	Establishment Name	Location
3005370583	KORVIS LLC (DBA Ascential Medical & Life Sciences)	Corvallis, OR, US
3002773840	BioFire Diagnostics, LLC	Salt Lake City, UT, US
3007361513	EUROIMMUN Medizinische Labordiagnostika AG	Dassow Mecklenburg-Western Pomerania, DE
2243471	ROCHE MOLECULAR SYSTEMS, INC.	Branchburg, NJ, US
3006028115	Luminex Corporation	Northbrook, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005269352. Last updated year: 2026. Please use registration number 3005269352 when referencing this establishment in official correspondence.