AutoDELFIA Neonatal 17α-OH-progesterone kit

Basic Information

• Brand Name: AutoDELFIA Neonatal 17α-OH-progesterone kit
• Primary DI: 06438147292486
• Version / Model: B024-112
• Catalog Number: B024-112
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-16
• Public Version: 1
• Public Version Date: 2018-12-17
• Public Version Status: New
• Public Device Record Key: a57e2204-71ed-42ea-a179-852e371eb23f

Device Description

For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

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: 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
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	862.1395	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61469	17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147292486	GS1

Premarket Submissions

Submission Number	Supplement Number
K081922	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius