AutoDELFIA hCG kit

Basic Information

• Brand Name: AutoDELFIA hCG kit
• Primary DI: 06438147009343
• Version / Model: B007-112
• Catalog Number: B007-112
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-11
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 8b86f2b6-31d7-4f45-b0de-d6b0cc6f4605

Device Description

Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG).

Device Characteristics

• Single Use: No
• 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
JHJ	Agglutination Method, Human Chorionic Gonadotropin	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58787	Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen using a fluorescent immunoassay method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147009343	GS1