Teco Diagnostics H. pylori Card Test

Basic Information

• Brand Name: Teco Diagnostics H. pylori Card Test
• Primary DI: 10673486002393
• Version / Model: H730-A
• Catalog Number: H730-A
• Company Name: TECO DIAGNOSTICS
• Labeler DUNS: 185067774
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-16
• Public Version: 1
• Public Version Date: 2024-01-24
• Public Version Status: New
• Public Device Record Key: d1da0287-dc7f-4689-8234-7dddbf70e200

Device Description

Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum. The test is intended for professional use as an aid in the diagnosis of H. pylori infections.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
LYR	Helicobacter Pylori	Microbiology	866.3110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65844	Helicobacter pylori immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Helicobacter pylori 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 to detect infection with H. pylori, which is associated with gastroduodenal disorders such as active chronic gastritis and gastric/duodenal ulcers. 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	10673486002393	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K024360	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius