Agena Bioscience Inc

FDA Filings

This page includes the latest FDA filings for Agena Bioscience Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010962166
FEI Number3010962166
NameAGENA BIOSCIENCE INCORPORATED
Owner & OperatorAgena Bioscience Incorporated
Contact Address4755 Eastgate Mall
San Diego CA 92121 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4755 Eastgate Mall
San Diego, CA 92121 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
AGENA BIOSCIENCE, INC.
Calibrant 004362020-09-16
AGENA BIOSCIENCE, INC.
SpectroChip CPM Kit (10x96) 10600F2020-09-16
AGENA BIOSCIENCE, INC.
SpectroChip CPM Kit (2x96) 10610F2020-09-16
AGENA BIOSCIENCE, INC.
MassARRAY Clean Resin 28g 80402020-09-16
AGENA BIOSCIENCE, INC.
SpectroChip Standalone Chip Only) 86082020-09-16
AGENA BIOSCIENCE, INC.
CPM Dx 312452020-09-16
AGENA BIOSCIENCE, INC.
MassARRAAY Dx 2600502020-09-16
AGENA BIOSCIENCE INCORPORATED
MassARRAY Dx System2018-12-19
AGENA BIOSCIENCE INCORPORATED
iPLEX Pro2017-11-14
AGENA BIOSCIENCE INCORPORATED
iPLEX Gold2017-11-14
AGENA BIOSCIENCE INCORPORATED
IMPACT Dx System2014-06-27
AGENA BIOSCIENCE INCORPORATED
IMPACT Dx Factor V Leiden and Factor II Genotyping Test2014-06-27
AGENA BIOSCIENCE INCORPORATED
IMPACT Dx Combined Function System2014-06-27

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019052742744Yantian,China (Mainland) -> Los Angeles, CaliforniaAL BRACKET5 PKG

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