Anti-dsDNA IgM ELISA EIA-3564

GUDID 00404847435641

Anti-dsDNA IgM ELISA is a test system for the quantitative measurement of IgM class autoantibodies against double-stranded DNA (dsDNA) in human serum or plasma.

DRG Instruments Gesellschaft mit beschränkter Haftung

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00404847435641
• NIH Device Record Key: 09d725a4-59bf-4036-83a9-a3a12d0fe0c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-dsDNA IgM ELISA
• Version Model Number: N/A
• Catalog Number: EIA-3564
• Company DUNS: 317134468
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(973)564-7555
• Email: corp@drg-international.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00404847435641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953671

FDA Product Code

• LRM: ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL

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: 2019-06-18
• Device Publish Date: 2019-06-10

On-Brand Devices [Anti-dsDNA IgM ELISA]

• 00404847435641: Anti-dsDNA IgM ELISA is a test system for the quantitative measurement of IgM class autoantibodi
• 04048474035643: Anti-dsDNA IgM ELISA is a test system for the quantitative measurement of IgM class autoantibodi