E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]

GUDID 08305900070781

Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	08305900070781
NIH Device Record Key	6ca1c311-2dd5-47db-80bd-2980c1bf4eb2
Commercial Distribution Discontinuation	2020-07-01
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]
Version Model Number	7078
Company DUNS	067647321
Company Name	BIOMERICA, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08305900070781 [Primary]

KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Steralize Prior To Use	false
Device Is Sterile	false

00083059070781	The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba
08305900070781	The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba