Swab-N-Go Home Test COVID-19 Ag

GUDID 08806133080849

Boditech Med Inc.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 08806133080849
• NIH Device Record Key: fa196e12-69e0-4a90-b44b-ed93099f6635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swab-N-Go Home Test COVID-19 Ag
• Version Model Number: CFPT-17
• Company DUNS: 689062203
• Company Name: Boditech Med Inc.
• Device Count: 2
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806133080849 [Primary]
GS1	18806133080846 [Unit of Use]

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: 2023-10-18
• Device Publish Date: 2023-10-10

Devices Manufactured by Boditech Med Inc.

• 08806133032008 - ichroma Reader: 2025-03-03
• 08806133080849 - Swab-N-Go Home Test COVID-19 Ag: 2023-10-18
• 08806133080849 - Swab-N-Go Home Test COVID-19 Ag: 2023-10-18
• 08806133010068 - AFIAS-50: 2022-09-16
• 08806133010099 - ichroma Reader: 2022-06-10
• 08806133010136 - ALFIS-3: 2021-12-14 FLUOROMETER FOR CLINICAL USE
• 08806133005262 - AFIAS TSH-SP: 2020-06-17 AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic
• 08806133005279 - AFIAS TSH-VB: 2020-06-17 AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro d
• 08806679001520 - ichroma™ CRP: 2020-06-17