ELISA Cardiolipin IgM Test System 2Z51051M

GUDID 00845533000321

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

ZEUS SCIENTIFIC, INC.

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533000321
• NIH Device Record Key: dcc8a6cc-199a-41b3-ab13-73bacc445313
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELISA Cardiolipin IgM Test System
• Version Model Number: 2Z51051M
• Catalog Number: 2Z51051M
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, 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: 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533000321 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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