Duns Number:691688915
Device Description: The MESACUP BP180 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELIS The MESACUP BP180 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 180 antibodies in human serum. The MESACUP BP180 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings.https://www.mblintl.com/products/rg-m7612-d
Catalog Number
7616US
Brand Name
MESACUP BP180 ELISA Kit
Version/Model Number
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
OEG
Product Code Name
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Public Device Record Key
9feb2b8f-527d-4026-8c22-bcb49f4752b8
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 |