Albumin
IMMULITE® 2000 Systems ALB Albumin - 10381453
Device Description
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 an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis and monitoring of diseases affecting protein metabolism (e.g., liver disease, kidney disease, severe malnutrition, malabsorption, burns).
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: DFJ
Device Name: Albumin, Rhodamine, 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 IdentifiersDevice Id: 00630414961569
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