EAGLE BIOSCIENCES, INC.

FDA Device Registration & Listing · Nashua, NH, US · Registration 3009014878

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009014878
FEI Number
3009014878
Entity Name
EAGLE BIOSCIENCES, INC.
City/State/Country
Nashua, NH, US
Establishment Address
20A NW Blvd, Suite 112, Nashua, NH 03063, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Eagle Biosciences, Inc. (Owner Number: 10077436)
Owner / Operator Contact Address
20A NW Blvd, Suite 112, Nashua, NH 03063, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pregnenolone ELISA DIAGNOSTICS BIOCHEM CANADA, INC. Biohit Healthcare (Hefei) Co. Ltd. Healgen Scientific LLC Jiangsu Bioperfectus Technologies Co., Ltd

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JNG Radioimmunoassay, Pregnenolone Clinical Chemistry Class 1 862.1615 2025-04-10
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-08-27
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2020-08-27

Official Correspondent

Daniel Keefe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Eagle Biosciences, Inc.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009014878. Last updated year: 2026. Please use registration number 3009014878 when referencing this establishment in official correspondence.
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