Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]

Basic Information

• Brand Name: Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]
• Primary DI: 00083059070637
• Version / Model: 7063
• Company Name: BIOMERICA, INC.
• Labeler DUNS: 067647321
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-01
• Public Version: 1
• Public Version Date: 2020-07-09
• Public Version Status: New
• Public Device Record Key: d608cd4e-c407-4a9a-bd74-2121e4d1f189

Device Description

The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic use only.

Device Characteristics

• Single Use: No
• 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
MHJ	Cryptosporidium Spp.	Microbiology	866.3220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52162	Cryptosporidium species 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 species of the parasitic protozoan Cryptosporidium in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083059070637	GS1

Customer Contacts

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