LiquidQC NEPHROCHECK Control

GUDID 00817238010257

LiquidQC™ NEPHROCHECK® Control For VIDAS® 3

CLINIQA CORPORATION

Multiple acute kidney injury (AKI) marker IVD, control

• Primary Device ID: 00817238010257
• NIH Device Record Key: b71e2efa-c24f-4fa1-b3be-55ad927c51ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiquidQC NEPHROCHECK Control
• Version Model Number: 83938
• Company DUNS: 078742335
• Company Name: CLINIQA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00817238010257 [Primary]

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: 2024-06-13
• Device Publish Date: 2024-06-05

Devices Manufactured by CLINIQA CORPORATION

• 00817238010257 - LiquidQC NEPHROCHECK Control: 2024-06-13LiquidQC™ NEPHROCHECK® Control For VIDAS® 3
• 00817238010257 - LiquidQC NEPHROCHECK Control: 2024-06-13 LiquidQC™ NEPHROCHECK® Control For VIDAS® 3
• 00817238010332 - NEPHROCHECK Calibration Verification: 2024-06-13 NEPHROCHECK® Calibration Verification For VIDAS® 3
• 00817238011520 - LQC Cardiac Control CS, mini pack: 2022-11-28 LQC Cardiac Control CS, mini pack
• 00817238010035 - LiquidQC CoV-2 IgG Control: 2020-10-02 CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays.
• 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