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

Giardia Spp. (MHI) (2) Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (KHW) (1) Antisera, All Groups, Salmonella Spp. (GRM) (1) Antisera, All Types, Shigella Spp. (GNB) (1) Reagent, Occult Blood (KHE) (1) Visual, Pregnancy Hcg, Prescription Use (JHI) (1)

Premarket Exempt

No Yes

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Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] - 08305900070699 Catalog Number :

Device Description : The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia antigen in fecal specimens. This assay is intended for research use only.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : Yes

Product Code : MHI

Prescription Use : No

Device Count : 1

E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] - 08305900070781 Catalog Number :

Device Description : The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detect The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba specific antigen in fecal specimens. This assay is intended for in vitro diagnostic use only.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : Yes

Product Code : KHW

Prescription Use : No

Device Count : 1

EZ Detect Colon Disease Test - 08305900100013 Catalog Number :

Device Description : Home Test For Hidden Blood in The Stool

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

EZ-SALMONELLA One-Step Salmonella species Rapid Test - 08305901007151 Catalog Number :

Device Description : The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determ The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional use only.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : Yes

Product Code : GRM

Prescription Use : No

Device Count : 1

EZ-SHIGELLA One-Step Shigella species Rapid Test - 08305901009155 Catalog Number :

Device Description : The Biomerica Shigella species test is a lateral flow immunoassay for the rapid The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : Yes

Product Code : GNB

Prescription Use : No

Device Count : 1

EZ-hCG Urine Pregnancy Test - 08305901048253 Catalog Number :

Device Description : The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative det The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

EZ-GIARDIA One-Step Giardia Test - 08305901501154 Catalog Number :

Device Description : The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualit The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection of Giardia antigens in human stool samples. The In Vitro test is intended for professional use only.

Device Class : 2

Duns Number: 067647321

Premarket Exempt : Yes

Product Code : MHI

Prescription Use : No

Device Count : 1

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