Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024647994

FEI Number

3024647994

Entity Name

Lusis Biosciences, Inc.

City/State/Country

Hayward, CA, US

Establishment Address

3500 Breakwater Court, Hayward, CA 94545, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Lusis Biosciences, Inc. (Owner Number: 10086722)

Owner / Operator Contact Address

3500 Breakwater Court, Hayward, CA 94545, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Sample Storage Reagent Nucleic Acid Extraction-Purification Kit 2 NATCH S-F11B System NATCH S-F11C System Nucleic Acid Extraction-Purification Kit 3 Nucleic Acid Extraction-Purification Kit 4 Q-Vera Pico 6X qPCR Instrument; Q-Vera Prima 96 qPCR Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2023-01-05
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2025-09-09
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2023-06-06
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-10-08

Official Correspondent

Julia Zhou

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lusis Biosciences, Inc.

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
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024647994. Last updated year: 2026. Please use registration number 3024647994 when referencing this establishment in official correspondence.