Identity
- Trade Name
- DSG-1 & DSG-3 ELISA Test System FDA UDI
- Generic Name
- Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- DSG1 48 wells and DSG3 48 wells. FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- 7593US FDA UDI
- Primary DI / UDI-DI
- 04987506015942 FDA UDI
- FDA Product Code
- NBO FDA UDI
- GMDN Term
- Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DSG-1 & DSG-3 ELISA Test System by Medical & Biological Laboratories Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medical & Biological Laboratories Co., Ltd.
Sources (1)
- FDA UDI 98794fe0-6a04-443e-acad-861830f950a5 37 fields · synced May 30, 2026