Cardiac Calibration Verifiers for Roche Systems

GUDID 00817238011636

Cardiac Calibration Verifiers for Roche Systems

CLINIQA CORPORATION

Multiple cardiac marker IVD, control

• Primary Device ID: 00817238011636
• NIH Device Record Key: 123fe7fa-a0d4-456e-a5d9-3e6cc41c8954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac Calibration Verifiers for Roche Systems
• Version Model Number: 98505
• 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	00817238011636 [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: 2020-02-10
• Device Publish Date: 2020-01-31

Devices Manufactured by CLINIQA CORPORATION

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• 00817238010028 - Cardiac CalVer for Abbott Systems, Level A-E: 2020-08-10 LiniCAL Cardiac CalVer for Abbott Systems, Level A LiniCAL Cardiac CalVer for Abbott Systems, Level B LiniCAL Cardiac CalVer for
• 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
• 00817238010691 - Protein 4 Calibration verifier Set for the Roche Integra: 2020-02-10 Protein 4 Calibration verifier Set for the Roche Integra
• 00817238010745 - Protein 2 Calibration Verifier set for the BCI AU: 2020-02-10 Protein 2 Calibration Verifier set for the BCI AU