Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008723200

FEI Number

3008723200

Entity Name

GROPEP BIOREAGENTS PTY LTD

City/State/Country

Adelaide South Australia, AU

Establishment Address

51 West Thebarton Road, Adelaide South Australia 5031, AU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GroPep Bioreagents Pty Ltd (Owner Number: 10053206)

Owner / Operator Contact Address

51 West Thebarton Road, Adelaide, AU-SA 5031, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2016-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

GroPep Bioreagents 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
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04

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3008156187	TECHNO-PATH MANUFACTURING LTD.	Ballina Tipperary, IE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008723200. Last updated year: 2026. Please use registration number 3008723200 when referencing this establishment in official correspondence.