Calibrator Y - 2 pack (cPSA Cal)

Calibrator Y
ADVIA Centaur® Systems. ACS:180® Systems Calibrator Y - 10310383

Device Description

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of complexed prostate specific antigen (cPSA) in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Lyophilized-until the expiration date on the vial label or reconstituted -21 days or onboard-8hours

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: NAF

Device Name: Antigen(Complexed),Prostate Specific,(Cpsa)

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: IM

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: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00630414451114

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