DSG-1 & DSG-3 ELISA Test System 7594US

GUDID 04987506017434

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.

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.

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

• Primary Device ID: 04987506017434
• NIH Device Record Key: b9fd31d3-616e-466b-8946-96c71e4d871d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSG-1 & DSG-3 ELISA Test System
• Version Model Number: DSG1 48 wells and DSG3 48 wells.
• Catalog Number: 7594US
• Company DUNS: 691688915
• Company Name: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com
• Phone: 8475445044
• Email: nadine.shabat@aesku-bion.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987506017434 [Primary]

FDA Product Code

• NBO: Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

On-Brand Devices [DSG-1 & DSG-3 ELISA Test System]

• 04987506015942: The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent assay for
• 04987506017434: The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent assay for