A Microalbumin test system is a device intended for the quantitative in vitro determination of Microalbumin concentration in urine
mALB - MA3828
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of microalbumin in a clinical specimen, using a nephelometry/turbidimetry method.
Environmental Conditions
- 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: DDZ
Device Name: Albumin, Fitc, 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 Identifiers
Device Id: 05055273204568
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