ImmunoCard STAT! EHEC 751630

GUDID 00840733101366

ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.

MERIDIAN BIOSCIENCE, INC.

Escherichia coli antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840733101366
• NIH Device Record Key: 14a92675-1b47-4c05-81ea-03ee3bca1038
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoCard STAT! EHEC
• Version Model Number: 751630
• Catalog Number: 751630
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733101366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062546

FDA Product Code

• GMZ: Antigens, All Types, Escherichia Coli

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: 2019-11-29
• Device Publish Date: 2019-11-21

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