Cardiac Control Complete +TnT level 2

GUDID 00817238011612

Cardiac Control Complete +TnT level 2

CLINIQA CORPORATION

Multiple cardiac marker IVD, control

• Primary Device ID: 00817238011612
• NIH Device Record Key: db496b7b-a50e-4626-9183-4032728ca400
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac Control Complete +TnT level 2
• Version Model Number: 91491
• Company DUNS: 078742335
• Company Name: CLINIQA CORPORATION
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817238011612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080973

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2019-02-25
• Device Publish Date: 2019-01-25

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