Biomerica Inc

FDA Filings

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

USANASDAQBMRADUNS 067647321

Biomerica Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3004569406
FEI Number3004569406
NameLouise Miyamoto
Owner & OperatorBiomerica, Inc.
Contact Address17571 Von Karman Ave --
Irvine CA 92614 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address17571 Von Karman Ave
Irvine, CA 92614 US
Establishment TypeManufacture Medical Device

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 Filings

Device
Company
DeviceDate
BIOMERICA, INC.
 EZ-GIARDIA One-Step Giardia Test 2021-09-02
BIOMERICA, INC.
 EZ-hCG Urine Pregnancy Test 2021-09-02
BIOMERICA, INC.
 EZ-SALMONELLA One-Step Salmonella species Rapid Test 2021-09-02
BIOMERICA, INC.
 EZ Detect Colon Disease Test 2021-09-02
BIOMERICA, INC.
 E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] 2021-09-02
BIOMERICA, INC.
 Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] 2021-09-02
BIOMERICA, INC.
 Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] 2021-09-02
BIOMERICA, INC.
 HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT 2021-09-02
BIOMERICA, INC.
 TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT 2021-09-02
BIOMERICA, INC.
 Myoglobin Enzyme Immunoassay Test Kit 2021-09-02
BIOMERICA, INC.
 EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] 2021-09-02
BIOMERICA, INC.
 Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] 2021-09-02
BIOMERICA, INC.
 ACTH [Adrenocorticotropic Hormone] ELISA 2021-09-02
BIOMERICA, INC.
 GAP®-IgG (Gastritis and Peptic Ulcer Test) 2021-09-02
BIOMERICA, INC.
 Aware Breast Self-Exam Pad 2021-09-02
BIOMERICA, INC.
 EZ Detect Fecal Occult Blood Test 2021-09-02
BIOMERICA, INC.
 EZ-GIARDIA One-Step Giardia Test 2020-07-09
BIOMERICA, INC.
 EZ-hCG Urine Pregnancy Test 2020-07-09
BIOMERICA, INC.
 EZ-SHIGELLA One-Step Shigella species Rapid Test 2020-07-09
BIOMERICA, INC.
 EZ-SALMONELLA One-Step Salmonella species Rapid Test 2020-07-09
BIOMERICA, INC.
 EZ Detect Colon Disease Test 2020-07-09
BIOMERICA, INC.
 E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] 2020-07-09
BIOMERICA, INC.
 Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] 2020-07-09
BIOMERICA, INC.
 Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] 2020-07-09
BIOMERICA, INC.
 HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT 2020-07-09
BIOMERICA, INC.
 TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT 2020-07-09
BIOMERICA, INC.
 Myoglobin Enzyme Immunoassay Test Kit 2020-07-09
BIOMERICA, INC.
 EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] 2020-07-09
BIOMERICA, INC.
 Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] 2020-07-09
BIOMERICA, INC.
 ACTH [Adrenocorticotropic Hormone] ELISA 2020-07-09
BIOMERICA, INC.
 Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] 2020-07-09
BIOMERICA, INC.
 GAP®-IgG (Gastritis and Peptic Ulcer Test) 2020-07-09
BIOMERICA, INC.
 Aware Breast Self-Exam Pad 2020-07-09
BIOMERICA, INC.
 Aware Breast Self-Exam Pad 2020-07-09
BIOMERICA, INC.
 EZ Detect Fecal Occult Blood Test 2020-07-09
Biomerica [Biomerica, Inc.]
COVID-19 IgG/IgM Rapid Test2020-03-26
BIOMERICA, INC.
 EZ-SHIGELLA One-Step Shigella species Rapid Test 2020-01-20
BIOMERICA, INC.
 Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] 2019-12-23
Louise Miyamoto [Biomerica, Inc.]
Microalbumin2018-11-01
Louise Miyamoto [Biomerica, Inc.]
Fortel Microalbumin Screening2018-11-01
Louise Miyamoto [Biomerica, Inc.]
Giardia Lateral Flow Rapid Test2016-11-07
Louise Miyamoto [Biomerica, Inc.]
C. difficile (GDH)2016-11-07
Louise Miyamoto [Biomerica, Inc.]
Listeria Lateral Flow Rapid Test2016-11-07
Louise Miyamoto [Biomerica, Inc.]
Salmonella Lateral Flow Rapid Test2016-11-07
Louise Miyamoto [Biomerica, Inc.]
Shigella Lateral Flow Rapid Test2016-11-07
Louise Miyamoto [Biomerica, Inc.]
EZ HCG2009-03-05
Louise Miyamoto [Biomerica, Inc.]
Aware Breast Pad2009-03-02
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
BIOMERICA, INC.
EZ-HCG URINE(PREGNANCY TEST)2001-02-21
Louise Miyamoto [Biomerica, Inc.]
MODIFIED EZ DETECT OCC2001-01-16
BIOMERICA, INC.
FREE T4 MICROWELL EIA, MODEL #70191998-09-24
BIOMERICA, INC.
TSH (MICROWELL) ELISA1996-09-19
BIOMERICA, INC.
T-3 MICROWELL EIA MODEL 70131996-03-19
BIOMERICA, INC.
ANTI-TPO1995-11-27
BIOMERICA, INC.
T4 MICROWELL EIA (ENZYME IMMUNOASSAY01995-06-29
BIOMERICA, INC.
THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY1994-07-18
BIOMERICA, INC.
GAP IGG H.PYLORI MODIFIED1992-03-04
BIOMERICA, INC.
GAP-IGG1991-08-22
Louise Miyamoto [Biomerica, Inc.]
LH Lateral Flow Rapid Test1985-11-22
Louise Miyamoto [Biomerica, Inc.]
FORTEL OVULATION1985-11-22

Related Finance Registrations
NCAGE Code5M390BIOMERICA INC
NCAGE Code6H7E1BIOMERICA, INC.
CAGE Code5M390BIOMERICA INC
CAGE Code6H7E1BIOMERICA, INC.
S.A.M. Registration6H7E1 [67647321]BIOMERICA, INC.
SEC0000073290BIOMERICA INC of DELAWARE
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020072213813Nhava Sheva,India -> Los Angeles, California106 TOP DISPOSABLE PLASTIC CASSETTE KB CDM 30 106 BOTTOM DISPOSABLE PLASTIC CASSETTE KB CDM 30168 PKG
2019032130319Ningpo ,China (Mainland) -> Long Beach, CaliforniaH S CODE 39269099 TOP DISPOSABLE PLASTIC CASS SABLE PLASTIC CAP501 PKG
2019031442932Ningpo ,China (Mainland) -> Long Beach, CaliforniaH S CODE 39269099 TOP DISPOSABLE PLASTIC CASS SABLE PLASTIC CAP501 PKG
2018081017672Shanghai ,China (Mainland) -> Los Angeles, CaliforniaFILLING MACHINE1 PKG
2018073039139Shanghai ,China (Mainland) -> Los Angeles, CaliforniaFILLING MACHINE1 PKG
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