Prostate Specific Antigen (PSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL

Prostate Specific Antigen (PSA)
Atellica IM PSA MCM - 10995664

Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Store Upright, 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: LTJ

Device Name: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.6010

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 00630414599823

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