New Life Diagnostics

Basic Information

• Brand Name: New Life Diagnostics
• Primary DI: 00850078606112
• Version / Model: Cysticercosis (T. solium) IgG ELISA Kit
• Catalog Number: 5013
• Company Name: NEW LIFE DIAGNOSTICS LLC
• Labeler DUNS: 081986839
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-13
• Public Version: 1
• Public Version Date: 2026-04-21
• Public Version Status: New
• Public Device Record Key: 228631b7-3149-4ebc-8938-308eff5899f2

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
52413	Taenia solium immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Taenia solium in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Taenia solium, the parasitic tapeworm associated with cysticercosis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850078606112	GS1