Cardiac Marker Control VS

GUDID 00817238010042

Cardiac Marker Control VS Tri-Levels

CLINIQA CORPORATION

Multiple cardiac marker IVD, control

• Primary Device ID: 00817238010042
• NIH Device Record Key: 45039e64-620b-458d-9b60-9c9955ad86da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac Marker Control VS
• Version Model Number: 91474
• 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	00817238010042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062916

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-04
• Device Publish Date: 2017-01-19

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• 00817238010660 - LiniCAL Calibration Verifiers Protein 1 for che Systems Levels A-F: 2020-02-10 LiniCAL Calibration Verifiers Protein 1 for che Systems Levels A-F
• 00817238010677 - Protein 2 Calibration Verifier Set for the Roche Integra: 2020-02-10 Protein 2 Calibration Verifier Set for the Roche Integra
• 00817238010684 - Protein 3 Calibration verifier Set for the Roche Integra: 2020-02-10 Protein 3 Calibration verifier Set for the Roche Integra