FDA.reportPublic FDA data

SCoV-2 Ag Detect™ Rapid Test

Primary DI
B379COVAF501
Brand
SCoV-2 Ag Detect™ Rapid Test
Company
INBIOS INTERNATIONAL, INC
Model
COVAF-50
Device description
POC COVID-19 antigen test, 50tests/kit
Published
2024-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient SettingsMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B379COVAF501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004006628
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B379COVGRE1SCoV-2 Detect™ IgG Rapid TestCOVG-RE2022-12-08
B379RCFP251COVID/Flu A&B RespiraDXTM Rapid TestRCFP-25RCFP-252025-10-06
B379RCFPCK101COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (10 sets)RCFP-CK102025-10-06
B379RCFPCK21COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (1 set)RCFP-CK22025-10-06
B379RCFS21COVID/Flu A&B RespiraDXTM Rapid Self-TestRCFS-2RCFS-22025-10-06
B379RCFS41COVID/Flu A&B RespiraDXTM Rapid Self-TestRCFS-4RCFS-42025-10-06
B379COV2E0Smart DetectTM SARS-CoV-2 rRT-PCR KitCOV2-E2020-07-15
B379COVAF201SCoV-2 Ag Detect™ Rapid TestCOVAF-202024-09-13
B379STNG11Strongy DetectTM IgG ELISASTNG-12024-09-13
B379ZKM21ZIKV Detect™ 2.0 IgM Capture ELISAIVD2019-05-24
B379COVNE1SCoV-2 Detect™ Neutralizing Ab ELISACOVN-E2022-12-08
B379C19S21COVID-19 Detect™ Rapid Self -TestC19S-22026-01-16
B379RCFPCK201COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets)RCFP-CK202025-10-06
B379AAP11Active Anthrax Detect Plus Rapid TestAAP-12023-03-03
B379CAGS21SCoV-2 Ag Detect™ Rapid Self-TestCAGS-22022-12-08
B379COVAGRC1SCoV-2 Ag Detect™ Rapid TestCOVAG-RC2022-12-08
B379COVEG1SCoV-2 Detect™ IgG ELISACOVE-G2022-12-08
B379COVEM1SCoV-2 Detect™ IgM ELISACOVE-M2022-12-08
B379CL0251CL Detect Rapid Test for Cutaneous LeishmaniasisCL025CL0252018-09-24
B379CP0501Chagas Detect™ Plus Rapid TestCP050CP0502018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816862028416WELLlife™WONDFO USA CO., LTD.QVF2026-06-01
00742860100673OSOM COVID-19 TestSEKISUI DIAGNOSTICS, LLCQVF2026-01-19
10742860100670OSOM COVID-19 TestSEKISUI DIAGNOSTICS, LLCQVF2026-01-19
00382902560920BD Veritor System for Rapid Detection of SARS-CoV-2BECTON, DICKINSON AND COMPANYQVF2025-08-21
30382902560921BD Veritor System for Rapid Detection of SARS-CoV-2BECTON, DICKINSON AND COMPANYQVF2025-08-21
B379COVAF201SCoV-2 Ag Detect™ Rapid TestINBIOS INTERNATIONAL, INCQVF2024-09-13
30014613339755Sofia 2QUIDEL CORPORATIONQVF2023-03-28