IDS-iSYS 25 VitDS Calibrator Set

Basic Information

• Brand Name: IDS-iSYS 25 VitDS Calibrator Set
• Primary DI: 05060169695320
• Version / Model: IS-2520N
• Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED
• Labeler DUNS: 494268600
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-26
• Public Version: 2
• Public Version Date: 2022-12-19
• Public Version Status: Update
• Public Device Record Key: cfe8bef2-94fb-4bb1-ab11-184540154671

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
54476	Multiple form 25-hydroxy Vitamin D IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060169695320	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161831	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the calibrators in an upright position in the dark at 2 - 8 °C. Do not freeze the calibrators.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius