AccessGUDID - DEVICE: Microalbumin ELISA (B24224MABHUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Microalbumin ELISA
Version or Model: 24-MABHU-E01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 24-MABHU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24224MABHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date: December 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DCF	Albumin, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e130076c-8771-4c53-ae36-a75ca6354d7d
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: January 16, 2018