Microalbumin ELISA

Basic Information

• Brand Name: Microalbumin ELISA
• Primary DI: B24224MABHUE010
• Version / Model: 24-MABHU-E01
• Catalog Number: 24-MABHU-E01
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Labeler DUNS: 784143778
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-16
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: e130076c-8771-4c53-ae36-a75ca6354d7d
• Distribution End Date: 2020-12-09

Device Description

The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin competes with albumin in samples for limited antibody binding sites on the microplate. After incubation for a fixed time, separation of bound from free is achieved by simple decantation and plate washing. The enzyme activity on the plate is measured using an enzyme substrate and a chromogen. The absorbency of the color developed is read in an ELISA colorimetric reader. The measured absorbance is inversely proportional to the concentration of bound albumin in the microplate. The concentration of albumin in the urine is determined from a calibration curve.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DCF	Albumin, Antigen, Antiserum, Control	Immunology	866.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53598	Albumin IVD, kit, enzyme immunoassay (EIA)	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 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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B24224MABHUE010	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius