Biomerica

FDA Filings

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

FDA Registration(s)
Registration Number2025099
FEI Number3007981058
NameBiomerica
Owner & OperatorBiomerica, Inc.
Contact Address17571 Von Karman Ave
Irvine CA 92614 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address17571 Von Karman Ave
Irvine, CA 92614 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Device in the United States for Export Only

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
Biomerica [Biomerica, Inc.]
COVID-19 IgG/IgM Rapid Test2020-03-26
Biomerica [Biomerica, Inc.]
EPO ELISA2007-12-06
Biomerica [Biomerica, Inc.]
Aware Pad (Breast Self-Exam)2007-12-06
Biomerica [Biomerica, Inc.]
ACTH ELISA Kit2007-12-06
Biomerica [Biomerica, Inc.]
Calcitonin ELISA2007-12-06
Biomerica [Biomerica, Inc.]
Intact-PTH ELISA2007-12-06
Biomerica [Biomerica, Inc.]
Anti-TPO ELISA2007-12-06
Biomerica [Biomerica, Inc.]
EZ-LH2007-12-06
Biomerica [Biomerica, Inc.]
Anti-TG ELISA2007-12-06
Biomerica [Biomerica, Inc.]
GAP IgG ELISA2007-12-06
Biomerica [Biomerica, Inc.]
EZ Detect2007-12-06
Biomerica [Biomerica, Inc.]
One Step Buprenorphine Test2007-12-06
Biomerica [Biomerica, Inc.]
Myoglobin ELISA2007-12-06
Biomerica [Biomerica, Inc.]
One Step Ecstasy Test2007-12-06
Biomerica [Biomerica, Inc.]
One Step Tricyclic Antidepressants2007-12-06
Biomerica [Biomerica, Inc.]
Human Cardiac Troponin I ELISA2007-12-06
Biomerica [Biomerica, Inc.]
One Step Barbiturates Test2007-12-06
Biomerica [Biomerica, Inc.]
One Step Methadone Test2007-12-06
Biomerica [Biomerica, Inc.]
One Step Benzodiazepines Test2007-12-06
Biomerica [Biomerica, Inc.]
One Step Phencyclidine Test2007-12-06
Biomerica [Biomerica, Inc.]
One Step Amphetamine Test2007-12-06
Biomerica [Biomerica, Inc.]
One Step Methamphetamine Test2007-12-06
Biomerica [Biomerica, Inc.]
One Step Opiates Test2007-12-06
Biomerica [Biomerica, Inc.]
One Step Cocaine Test2007-12-06
Biomerica [Biomerica, Inc.]
EZ-HCG2007-12-06
Biomerica [Biomerica, Inc.]
hs C-Reactive Protein ELISA2007-12-06
Biomerica [Biomerica, Inc.]
One Step THC Test2007-12-06

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019111331503Ningpo ,China (Mainland) -> Long Beach, CaliforniaPRINTED PLASTIC POUCH FOR P/N 50712 PKG
2018011943064Shanghai ,China (Mainland) -> Long Beach, CaliforniaSILICA GEL DESICCANT2 PKG
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