INSTANT-VIEW Troponin I Serum Cassette Test

Basic Information

• Brand Name: INSTANT-VIEW Troponin I Serum Cassette Test
• Primary DI: 10796918001792
• Version / Model: 05-8572
• Company Name: ALFA SCIENTIFIC DESIGNS, INC.
• Labeler DUNS: 176391167
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 0402d6c7-b5f2-4227-b944-25ccaf1069e9

Device Description

INSTANT-VIEW Troponin I Serum Cassette Test

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: 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
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46989	Troponin I IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10796918001792	GS1
Unit of Use	00796918001795	GS1