FDA.reportPublic FDA data

DSG-1 & DSG-3 ELISA Test System

Primary DI
04987506017434
Brand
DSG-1 & DSG-3 ELISA Test System
Company
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Model
DSG1 48 wells and DSG3 48 wells.
Catalog number
7594US
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.
Published
2023-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987506017434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987506017434049875060174344987506017434

GMDN Terms#

Term, Definition table
TermDefinition
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8475445044nadine.shabat@aesku-bion.com

Regulatory Flags#

DUNS number
691688915
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987506015942DSG-1 & DSG-3 ELISA Test SystemDSG1 48 wells and DSG3 48 wells.7593US2020-02-17
04987506015959MESACUP BP180 ELISA Kit48 wells7695US2020-02-17
04987506015966MESACUP BP230 ELISA Kit48 wells7613US2020-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987506015942DSG-1 & DSG-3 ELISA Test SystemMEDICAL & BIOLOGICAL LABORATORIES CO., LTD.NBO2020-02-17
04049016089186Anti-Desmoglein 1 ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNBO2016-09-24
04049016089193Anti-Desmoglein 3 ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNBO2016-09-24
B110RGM7593D0DSG 1 & DSG 3 ELISA TESTBion Enterprises, Ltd.NBO2016-09-12