FastPack® IP Vitamin D Kit Complete

Basic Information

• Brand Name: FastPack® IP Vitamin D Kit Complete
• Primary DI: 10816467020157
• Version / Model: Vit. D Immunoassay
• Catalog Number: 25000068, 25000073
• Company Name: QUALIGEN INC.
• Labeler DUNS: 959103565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e39b6f6d-f902-498f-a99d-385b23ee771e

Device Description

30 Test Vit. D Immunoassay Complete Kit w/Cal and Control

Device Characteristics

• Single Use: Yes
• 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
MRG	System, Test, Vitamin D	Clinical Chemistry	862.1825	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60922	Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816467020157	GS1
Unit of Use	00816467020150	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123983	000

Storage Conditions

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