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DSG-1 & DSG-3 ELISA Test System

FDA UDI

Class II (US FDA UDI)

by Medical & Biological Laboratories Co., Ltd.

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. 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. FDA UDI

Identifiers

Catalog Number
7594US FDA UDI
Primary DI / UDI-DI
04987506017434 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
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

Category: Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical & Biological Laboratories Co., Ltd.

Sources (1)

  • FDA UDI b9fd31d3-616e-466b-8946-96c71e4d871d 36 fields · synced May 31, 2026