Cardiolipin IgM ELISA EIA-2789

GUDID 00840239027894

The Cardiolipin IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi- quantitative measurement of circulating IgM autoantibodies to Cardiolipin

DRG International Inc

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239027894
• NIH Device Record Key: 1fbd2f63-b6f0-44f8-8ae7-20b6a48fe324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiolipin IgM ELISA
• Version Model Number: EIA-2789
• Catalog Number: EIA-2789
• Company DUNS: 075150847
• Company Name: DRG International Inc
• 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: true
• 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: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239027894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981021

FDA Product Code

• DDC: Thyroglobulin, Antigen, Antiserum, 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: 2023-09-01
• Device Publish Date: 2023-08-24

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