Emit ® 2000 Cyclosporine Specific Negative Calibrator
Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator - 10445377
Device Description
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.
Environmental Conditions
- -20.00
- -70.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MKW
Device Name: Cyclosporine
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1235
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00842768001475
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 00630414024523
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A