Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025663244

FEI Number

3025663244

Entity Name

RPI BIOSOLUTIONS

City/State/Country

Mundelein, IL, US

Establishment Address

300 TERRACE DR. SUITE A, Mundelein, IL 60060, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RPI BIOSOLUTIONS (Owner Number: 10086908)

Owner / Operator Contact Address

300 TERRACE DR. SUITE A, Mundelein, IL 60060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alinity m Diluent Solution Alinity m Lysis Solution Alinity m Lysis Solution Alinity m Diluent Solution Alinity m Lysis Solution Alinity m Diluent Solution Alinity m Diluent Solution Alinity m Lysis Solution PrimeStore MTM Alinity m Lysis Solution Alinity m Diluent Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QLX	Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna	Microbiology	Class 2	866.3183	2023-01-20
QUM	Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	Microbiology	Class 2	866.3958	2023-01-26
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2023-01-20
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2023-01-20
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2025-06-27
MKT	Hepatitis Viral B Dna Detection	Microbiology	Class 2	866.3174	2023-01-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RPI BIOSOLUTIONS

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Similar Registrations

Registration Number	Establishment Name	Location
3005248192	ABBOTT MOLECULAR, INC.	Des Plaines, IL, US
2243471	ROCHE MOLECULAR SYSTEMS, INC.	Branchburg, NJ, US
2023365	DiaSorin Molecular LLC	CYPRESS, CA, US
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3004141078	ROCHE MOLECULAR SYSTEMS, INC.	PLEASANTON, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025663244. Last updated year: 2026. Please use registration number 3025663244 when referencing this establishment in official correspondence.