DENV Detect IgM Capture ELISA DDMS-1

GUDID B379DDMS11

INBIOS INTERNATIONAL, INC

Dengue virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B379DDMS11
• NIH Device Record Key: c0a790d3-efc6-4ba0-91bb-b2f54378a2a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENV Detect IgM Capture ELISA
• Version Model Number: DDMS1
• Catalog Number: DDMS-1
• 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: false
• 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	B379DDMS11 [Primary]

FDA Product Code

• OSU: Dengue Serological Reagents

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-28

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