Alinity i Sirolimus Calibrators

Alinity i Sirolimus Calibrators
Alinity - 09P4101

Device Description

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug rapamycin (sirolimus) in a clinical specimen.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

0.00
N/A

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JIT

Device Name: Calibrator, Secondary

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1150

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 00380740150983

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