Active Anthrax Detect Plus Rapid Test

GUDID B379AAP11

INBIOS INTERNATIONAL, INC

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• Primary Device ID: B379AAP11
• NIH Device Record Key: cb4547db-8be5-4d2e-8ae5-b90a51e6b6ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Active Anthrax Detect Plus Rapid Test
• Version Model Number: AAP-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: 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	B379AAP11 [Primary]

FDA Product Code

• QUU: Lateral Flow Immunoassay For Protein Detection And Identification Of Bacillus Anthracis

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: 2023-03-13
• Device Publish Date: 2023-03-03

Devices Manufactured by INBIOS INTERNATIONAL, INC

• B379AAP11 - Active Anthrax Detect Plus Rapid Test: 2023-03-13
• B379AAP11 - Active Anthrax Detect Plus Rapid Test: 2023-03-13
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• B379ZKM21 - ZIKV Detect™ 2.0 IgM Capture ELISA: 2019-06-03
• B379CL0251 - CL Detect Rapid Test for Cutaneous Leishmaniasis: 2018-10-25
• B379CP0501 - Chagas Detect™ Plus Rapid Test: 2018-10-25
• B379DNS111 - DENV Detect NS1 ELISA: 2018-10-25
• B379INS0251 - Kalazar Detect Rapid Test for Visceral Leishmanias: 2018-10-25
• B379DDMS11 - DENV Detect IgM Capture ELISA: 2018-03-29