GAP®-IgG (Gastritis and Peptic Ulcer Test)

GUDID 08305900070040

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	08305900070040
NIH Device Record Key	65288d97-f5ac-4fe4-b3a0-24da90b4dbf6
Commercial Distribution Discontinuation	2020-07-01
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	GAP®-IgG (Gastritis and Peptic Ulcer Test)
Version Model Number	7004
Company DUNS	067647321
Company Name	BIOMERICA, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	08305900070040 [Primary]

LYR	Helicobacter Pylori

Steralize Prior To Use	false
Device Is Sterile	false

00083059070040	The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicob
08305900070040	The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicob