FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DSG-1 & DSG-3 ELISA Test System
DI: 04987506015942
·
Model: DSG1 48 wells and DSG3 48 wells.
·
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DSG-1 & DSG-3 ELISA Test System
- Primary DI
- 04987506015942
- Version / Model
- DSG1 48 wells and DSG3 48 wells.
- Catalog Number
- 7593US
- Company Name
- MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
- Labeler DUNS
- 691688915
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-17
- Public Version
- 4
- Public Version Date
- 2023-09-04
- Public Version Status
- Update
- Public Device Record Key
- 98794fe0-6a04-443e-acad-861830f950a5
- Distribution End Date
- 2023-09-04
Device 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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBO | Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62293 | Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody 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 antibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of the autoimmune pemphigus skin diseases pemphigus foliaceus and pemphigus vulgaris. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987506015942 | GS1 |
Customer Contacts
- Phone
- 8475445044
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius