Entamoeba histolytica IgG ELISA EIA-3830

GUDID 04048474038309

The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).

DRG Instruments Gesellschaft mit beschränkter Haftung

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

• Primary Device ID: 04048474038309
• NIH Device Record Key: 0faa2a0e-328a-4c9d-91bc-9f59ef413dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entamoeba histolytica IgG ELISA
• Version Model Number: EIA-3830
• Catalog Number: EIA-3830
• 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

Customer Support Contacts

• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048474038309 [Primary]

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [Entamoeba histolytica IgG ELISA]

• 04048474034745: The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodie
• 04048474038309: The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class a