Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator

Basic Information

• Brand Name: Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator
• Primary DI: 00842768001475
• Version / Model: 10445377
• Catalog Number: 6R319UL
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 20d112dc-b7dc-49f5-8e3d-ef11c5d8c619

Device Description

Emit ® 2000 Cyclosporine Specific Negative Calibrator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
MKW	CYCLOSPORINE	Clinical Chemistry	862.1235	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55440	Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768001475	GS1
Unit of Use	00630414024523	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P920031	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -70 – -20 Degrees Celsius