E.histolytica Antibody 96 Test with Calibrator

Basic Information

• Brand Name: E.histolytica Antibody 96 Test with Calibrator
• Primary DI: 00813545025403
• Version / Model: EH-96C
• Catalog Number: EH-96C
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d03272dd-314b-4e90-ac28-3ddcdc989b78

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWD	Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp	Microbiology	866.3220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52221	Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Entamoeba histolytica in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545025403	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]