Chagas Detect™ Plus Rapid Test CP050

GUDID B379CP0501

INBIOS INTERNATIONAL, INC

Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, immunochromatographic test (ICT), rapid Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, immunochromatographic test (ICT), rapid Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

• Primary Device ID: B379CP0501
• NIH Device Record Key: 41b09e46-0cea-4144-a4f1-44f9849c31b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chagas Detect™ Plus Rapid Test
• Version Model Number: CP050
• Catalog Number: CP050
• Company DUNS: 004006628
• Company Name: INBIOS INTERNATIONAL, INC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B379CP0501 [Primary]

FDA Product Code

• MIU: Enzyme Linked Immunosorbent Assay, T. Cruzi

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: 2018-10-25
• Device Publish Date: 2018-09-24

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