Anti-Cardiolipin Screen ELISA EIA-3589

GUDID 00404847435894

Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma.

DRG Instruments Gesellschaft mit beschränkter Haftung

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00404847435894
• NIH Device Record Key: 1f1564fa-bda8-4ba6-b95b-93c520c03af7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Cardiolipin Screen ELISA
• Version Model Number: N/A
• Catalog Number: EIA-3589
• 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	00404847435894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962926

FDA Product Code

• MID: SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL

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-Cardiolipin Screen ELISA]

• 00404847435894: Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and
• 04048474035896: Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and