FDA.reportPublic FDA data

COVID-19 Detect™ Rapid Self -Test

Primary DI
B379C19S21
Brand
COVID-19 Detect™ Rapid Self -Test
Company
INBIOS INTERNATIONAL, INC
Model
C19S-2
Published
2026-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QYTOver-The-Counter Covid-19 Antigen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYTOver-The-Counter Covid-19 Antigen TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B379C19S21PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingA 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 intended to be used for self-testing by a layperson in the home or similar environment.

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
B379COVAF501SCoV-2 Ag Detect™ Rapid TestCOVAF-502024-09-13
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
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
00682607002306Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
20682607660265Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TGenabio Diagnostics Inc.QYT2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TGenabio Diagnostics Inc.QYT2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TGenabio Diagnostics Inc.QYT2026-01-21
00850010224275CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224435CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00050428101735CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2025-08-08
00816862027402WELLlife™ WONDFO USA CO., LTD.QYT2025-07-03
10816862027409WELLlife™ WONDFO USA CO., LTD.QYT2025-07-03
00194346415908equateWAL-MART STORES, INC.QYT2025-05-22
10194346415905equateWAL-MART STORES, INC.QYT2025-05-22
00816862027280WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
10816862027287WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
06930251802365equateWAL-MART STORES, INC.QYT2025-04-05
16930251802362equateWAL-MART STORES, INC.QYT2025-04-05
00816862026252WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026276WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026290WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026259WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026273WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026297WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026238WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
00816862026177WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
10816862026235WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
30014613340188CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2024-11-20
00850042559666CorDx TyfastCORETESTS, INC.QYT2024-09-05
00850042559925CorDx TyfastCORETESTS, INC.QYT2024-09-05
00850042559932CorDx TyfastCORETESTS, INC.QYT2024-09-05