iKitten

Basic Information

• Brand Name: iKitten
• Primary DI: 16974488990683
• Version / Model: CY-GIAAG-01
• Company Name: Huachenyang (Shenzhen) Technology Co., Ltd
• Labeler DUNS: 548237157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-04
• Public Version: 1
• Public Version Date: 2023-09-12
• Public Version Status: New
• Public Device Record Key: e4072a8e-b7e4-4bf9-b61b-e3382af7496e

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
52249	Giardia lamblia antigen 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 antigens from the parasitic protozoan Giardia lamblia 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
Package	26974488990680	GS1	carton	500	In Commercial Distribution
Primary	16974488990683	GS1