For the quantitative measurement of albumin in human serum and plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System

For the quantitative measurement of albumin in human serum and plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System
DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin - 10445894

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a nephelometry/turbidimetry method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DCF

Device Name: Albumin, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 866.5040

Third Party Flag: N

Medical Specialty: IM

Device Id: 00842768006098

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: 00842768019999

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