FDA.reportPublic FDA data

OSOM Flu SARS-CoV-2 Combo Home

Primary DI
00742860000089
Brand
OSOM Flu SARS-CoV-2 Combo Home
Company
SEKISUI DIAGNOSTICS, LLC
Model
1074
Catalog number
1074
Device description
OSOM Flu SARS-CoV-2 Combo Home
Published
2024-12-16
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
QKPCoronavirus Antigen Detection Test System.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKPCoronavirus Antigen Detection Test System.UnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50742860100654PackageGS11In Commercial Distribution
00742860000089PrimaryGS10
10742860100656Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074286010065450742860100654
00742860000089007428600000897428600000890742860000089
1074286010065610742860100656

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus 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 multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.

Regulatory Flags#

DUNS number
966812344
Device count
2
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860100413Acucy Printer Paper10192026-02-27
10742860100410Acucy Printer Paper10192026-02-27
00742860100444Acucy Reader A/C Adapter10432026-02-27
00742860100475Acucy System Universal Drawer10512026-02-27
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
50742860100685OSOM BVBlue Transport Swabs1862026-02-23
00742860100338Acucy System10392019-09-24
00742860100673OSOM COVID-19 Test109210922026-01-19
10742860100670OSOM COVID-19 Test109210922026-01-19
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
10742860100052OSOM BV Blue 25T Kit1831832025-12-29
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B115ABCASS1CANAO25T1Advin COVID-19 Antigen Test @HomeADVIN BIOTECH, INC.QKP2025-12-29
50810172700074Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2025-08-01
60810172700071Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2025-08-01
00860013635107Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635114Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635121Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00197644204359Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00197644380435Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00197644563371Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00810143620184Genabio COVID-19 Rapid Self-Test KitGenabio Diagnostics Inc.QKP2025-01-13
00816862024609WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
10816862024606WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
00742860000027OSOM COVID-19 Antigen Rapid TestSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000034OSOM COVID-19 Antigen Control KitSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000041OSOM COVID-19 Antigen Home TestSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000072OSOM Flu SARS-CoV-2 Combo Control KitSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
50810172700081Speedy Swab Rapid COVID-19 & FLU A&B Self-Test WatMIND USAQKP2024-08-30
50810172700098Speedy Swab Rapid COVID-19 & FLU A&B Self-Test WatMIND USAQKP2024-08-30
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONQKP2024-08-08
00810172700079Speedy Swab Rapid COVID-19 & FLU A+B (4 Tests/Box)WatMIND USAQKP2024-08-08
00810172700086Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONQKP2024-08-08
10810172700083RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
10810172700090RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)WatMIND USAQKP2024-08-08
20810172700080RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
20810172700097RDB10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2024-08-08
30810172700087CARTON-RDB2V6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)WatMIND USAQKP2024-08-08
30810172700094CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)WatMIND USAQKP2024-08-08
40810172700084CARTON-RDB2V6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)WatMIND USAQKP2024-08-08
40810172700091CARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)WatMIND USAQKP2024-08-08