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

System, Imaging, Pulsed Echo, Ultrasonic (IYO) (2) Assay, Erythropoietin (GGT) (1) Helicobacter Pylori (LYR) (1) Immunoassay Method, Troponin Subunit (MMI) (1) Amplifier And Signal Conditioner, Biopotential (DRR) (1) Radioimmunoassay, Calcitonin (JKR) (1) Radioimmunoassay, Parathyroid Hormone (CEW) (1) Reagent, Occult Blood (KHE) (1) Radioimmunoassay, Acth (CKG) (1)

Premarket Exempt

No Yes

Clear

EZ Detect Fecal Occult Blood Test - 00083059010015 Catalog Number :

Device Description : The EZ DETECT Test is for in vitro qualitative detection of occult blood in the The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

Aware Breast Self-Exam Pad - 00083059012033 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

Aware Breast Self-Exam Pad - 00083059012071 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) - 00083059070040 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] - 00083059070224 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 - 00083059070231 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] - 00083059070248 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] - 00083059070255 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 - 00083059070309 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 - 00083059070316 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

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