ImmunoWELL Cardiolipin (IgM) Test 3100

GUDID 00613745031002

The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders.

Genbio

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00613745031002
• NIH Device Record Key: 4eb67405-22f4-465b-88bf-c9ea6b26fb16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoWELL Cardiolipin (IgM) Test
• Version Model Number: 800-3100
• Catalog Number: 3100
• Company DUNS: 940425333
• Company Name: Genbio
• 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: 858-592-9300
• Email: support@genbio.com
• Phone: 858-592-9300
• Email: support@genbio.com
• Phone: 858-592-9300
• Email: support@genbio.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613745031002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920401

FDA Product Code

• MID: System, Test, Anticardiolipin Immunological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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