AGENA BIOSCIENCE INCORPORATED

FDA Device Registration & Listing · San Diego, CA, US · Registration 3010962166

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
3010962166
FEI Number
3010962166
Entity Name
AGENA BIOSCIENCE INCORPORATED
City/State/Country
San Diego, CA, US
Establishment Address
4755 Eastgate Mall, San Diego, CA 92121, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Agena Bioscience Incorporated (Owner Number: 10047097)
Owner / Operator Contact Address
4755 Eastgate Mall, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

iPLEX Gold iPLEX Pro MassARRAY Dx System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PPM General Purpose Reagent Pathology Class 1 864.4010 2017-11-14
DOP Mass Spectrometer, Clinical Use Clinical Chemistry Class 1 862.2860 2018-12-19

Official Correspondent

Heath Metzler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Agena Bioscience Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010962166. Last updated year: 2026. Please use registration number 3010962166 when referencing this establishment in official correspondence.
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