Complexed Prostate-specific Antigen (cPSA) Pre-Treatment Reagent 1-pack

Complexed Prostate
ADVIA Centaur® cPSA PRE - 10310384

Device Description

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 complexed prostate specific antigen (cPSA) in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Store Upright, Protect from Light, Do not freeze, Resuspend.

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: 00630414451558

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