BIOMERICA, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Amplifier And Signal Conditioner, Biopotential (DRR) (1) Assay, Erythropoietin (GGT) (1) C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (1) Cryptosporidium Spp. (MHJ) (1) Helicobacter Pylori (LYR) (1) Immunoassay Method, Troponin Subunit (MMI) (1) Radioimmunoassay, Acth (CKG) (1) Radioimmunoassay, Calcitonin (JKR) (1) Radioimmunoassay, Parathyroid Hormone (CEW) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1)

Premarket Exempt

No Yes

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Aware Breast Self-Exam Pad - 08305900012033 Catalog Number :

Device Description : The Aware™ Pad is intended to be used as an aid for performing breast self-examination.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

GAP®-IgG (Gastritis and Peptic Ulcer Test) - 08305900070040 Catalog Number :

Device Description : The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antib The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori.

Device Class : 1

Duns Number: 067647321

Premarket Exempt : No

Product Code : LYR

Prescription Use : No

Device Count : 1

Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] - 08305900070224 Catalog Number :

Device Description : The Biomerica Intact-PTH ELISA is intended for the quantitative determination of The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. This assay is intended for in vitro diagnostic use.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : CEW

Prescription Use : No

Device Count : 1

ACTH [Adrenocorticotropic Hormone] ELISA - 08305900070231 Catalog Number :

Device Description : The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : CKG

Prescription Use : No

Device Count : 1

Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] - 08305900070248 Catalog Number :

Device Description : The Biomerica Calcitonin ELISA is intended for the quantitative determination of The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : JKR

Prescription Use : No

Device Count : 1

EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] - 08305900070255 Catalog Number :

Device Description : The Biomerica EPO ELISA is intended for the quantitative determination of Erythr The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : GGT

Prescription Use : No

Device Count : 1

Myoglobin Enzyme Immunoassay Test Kit - 08305900070309 Catalog Number :

Device Description : The Myoglobin ELISA is intended for the quantitative determination of myoglobin The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : DRR

Prescription Use : No

Device Count : 1

TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT - 08305900070316 Catalog Number :

Device Description : The cTnI ELISA is intended for the quantitative determination of cardiac troponi The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 1

HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT - 08305900070330 Catalog Number :

Device Description : The hsCRP ELISA is intended for the quantitative determination of C-reactive pro The hsCRP ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : DCK

Prescription Use : No

Device Count : 1

Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] - 08305900070637 Catalog Number :

Device Description : The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic use only.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : Yes

Product Code : MHJ

Prescription Use : No

Device Count : 1

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