LiquidQC CoV-2 IgG Control

GUDID 00817238010035

CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays.

CLINIQA CORPORATION

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

• Primary Device ID: 00817238010035
• NIH Device Record Key: 817fc778-bba2-4327-b5a9-201abb1f5fc6
• Commercial Distribution Discontinuation: 2020-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LiquidQC CoV-2 IgG Control
• Version Model Number: 91494
• 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: false
• 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	00817238010035 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2020-10-02
• Device Publish Date: 2020-09-24

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