Swab-N-Go Home Test COVID-19 Ag

GUDID 08806133080849

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

Steralize Prior To Use	false
Device Is Sterile	false

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
08806679002718 - ichroma™ iFOB	2020-06-17

Mark Image Registration \| Serial	Company Trademark Application Date
SWAB-N-GO HOME TEST COVID-19 AG 97477603 not registered Live/Pending	Boditech Med Inc. 2022-06-27