AutoDELFIA Inhibin A kit Level Calibrators

Basic Information

• Brand Name: AutoDELFIA Inhibin A kit Level Calibrators
• Primary DI: 06438147344406
• Version / Model: B064-112-P2
• Catalog Number: B064-112-P2
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-21
• Public Version: 1
• Public Version Date: 2018-12-24
• Public Version Status: New
• Public Device Record Key: e81e521d-de46-4249-a095-52db0b96269c

Device Description

Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.

Device Characteristics

• Single Use: No
• 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: Yes
• 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
NDR	Enzyme Immunoassay, Inhibin-A	Clinical Chemistry	862.1260	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62325	Inhibin A IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative detection of inhibin A in a clinical specimen, using a fluorescent immunoassay method. Inhibin A detection is useful in studies of human reproductive physiology (e.g., as an endocrine marker for monitoring ovarian function).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147344406	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -80 – -60 Degrees Celsius