Entamoeba histolytica Ag (stool) ELISA EIA-3473

GUDID 04048474034738

Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	04048474034738
NIH Device Record Key	af764d11-8a9d-4c8c-8a16-b5ff614b1bf0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Entamoeba histolytica Ag (stool) ELISA
Version Model Number	EIA-3473
Catalog Number	EIA-3473
Company DUNS	317134468
Company Name	DRG Instruments Gesellschaft mit beschränkter Haftung
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	04048474034738 [Primary]

GMO	Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.

Steralize Prior To Use	false
Device Is Sterile	false

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