Duns Number:691688915
Device Description: The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent ass The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent assay for the determination of autoantibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in human serum. The DSG-1 & DSG-3 ELISA Test System is intended for in vitro diagnostic use as an aid in diagnosis of certain pemphigus diseases.https://www.mblintl.com/products/rg-m7593-d
Catalog Number
7598US
Brand Name
DSG-1 & DSG-3 ELISA Test System
Version/Model Number
DSG1 48 wells and DSG3 48 wells.
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NBO
Product Code Name
Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
Public Device Record Key
98794fe0-6a04-443e-acad-861830f950a5
Public Version Date
February 25, 2020
Public Version Number
1
DI Record Publish Date
February 17, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |