GSP Neonatal Biotinidase kit

Basic Information

• Brand Name: GSP Neonatal Biotinidase kit
• Primary DI: 06438147330911
• Version / Model: 3307-001U
• Catalog Number: 3307-001U
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 80d84c78-40b7-4491-8a7a-f7e8f3db9327

Device Description

For the quantitative determination of human biotinidase activity in dried blood. Note: Kit contains multiple packages.

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
NAK	System,Test,Biotinidase	Clinical Chemistry	862.1118	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59250	Biotinidase IVD, kit, enzyme fluorescence	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the enzyme biotinidase in a clinical specimen, using an enzyme fluorescence method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147330911	GS1

Premarket Submissions

Submission Number	Supplement Number
K131284	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -30 – -16 Degrees Celsius