Duns Number:784143778
Device Description: The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin co The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin competes with albumin insamples for limited antibody binding sites on the microplate. After incubation for a fixed time, separation of bound fromfree is achieved by simple decantation and plate washing. The enzyme activity on the plate is measured using an enzymesubstrate and a chromogen. The absorbency of the color developed is read in an ELISA colorimetric reader. The measuredabsorbance is inversely proportional to the concentration of bound albumin in the microplate. The concentration ofalbumin in the urine is determined from a calibration curve.
Catalog Number
24-MABHU-E01
Brand Name
Microalbumin ELISA
Version/Model Number
24-MABHU-E01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 09, 2020
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DCF
Product Code Name
Albumin, Antigen, Antiserum, Control
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |