ORTHO

Basic Information

• Brand Name: ORTHO
• Primary DI: 10758750007745
• Version / Model: 6902412
• Catalog Number: 6902412
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 068715424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 4
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: b7f42b4f-d430-4863-b89e-e3d687c100fd

Device Description

T. CRUZI ELISA TEST SYSTEM 192T WW

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: No
• 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
MIU	ENZYME LINKED IMMUNOSORBENT ASSAY, T. CRUZI	Microbiology	866.3870	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52494	Trypanosoma cruzi immunoglobulin G (IgG)/IgM 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) and immunoglobulin M (IgM) antibodies to the parasitic protozoan Trypanosoma cruzi 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	10758750007745	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius