FDA.reportPublic FDA data

OSOM Flu Dipstick 25 Test Kit

Primary DI
00742860001901
Brand
OSOM Flu Dipstick 25 Test Kit
Company
Sekisui Diagnostics, LLC
Model
190
Catalog number
190
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GNXANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, CMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00742860001901PrimaryGS10
10742860001908Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00742860001901007428600019017428600019010742860001901
1074286000190810742860001908

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus 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 influenza A virus and/or influenza B virus 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.

Regulatory Flags#

DUNS number
966812344
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16
00742860000041OSOM COVID-19 Antigen Home Test1067-401067-402024-12-16
00742860000072OSOM Flu SARS-CoV-2 Combo Control Kit10792024-12-16
00742860000089OSOM Flu SARS-CoV-2 Combo Home107410742024-12-16
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
00742860100314OSOM Vaginal Transport Swab Set1851852018-04-05
00742860100390OSOM ULTRA PLUS FLU A&B Test10322020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control Kit10342020-06-01
00742860100673OSOM COVID-19 Test109210922026-01-19
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063401291Acetaminophen03R74202023-05-08
00628063401307Acetaminophen Calibrator03R74012023-05-08
00628063401314Alinity c Acetaminophen07P54202023-05-08
00628063401321Alinity c Acetaminophen Calibrator07P54012023-05-08
00628063401222DC-TROL LEVELS 1 & 2SM-0572020-03-30
00628063401116MicroalbuminSK252-20SK252-202019-10-02
00628063401185Acetaminophen AssaySK507-50SK507-502019-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16977977230024N/AZhengzhou Shiyi Biotech Co., Ltd.GNX2025-01-28
16977977230031N/AZhengzhou Shiyi Biotech Co., Ltd.GNX2025-01-28
26977977230021N/AZhengzhou Shiyi Biotech Co., Ltd.GNX2025-01-28
26977977230038N/AZhengzhou Shiyi Biotech Co., Ltd.GNX2025-01-28
05032384502981IMAGEN Influenza Virus A and BOXOID LIMITEDGNX2024-12-30
00855113008722ClearFitLONGEVITI NEURO SOLUTIONS LLCGNX2024-03-20
00855113008661Longeviti Convenience Kit 5.0LONGEVITI NEURO SOLUTIONS LLCGNX2024-03-15
08033891327514CHORUS INFLUENZA A IgGDIESSE DIAGNOSTICA SENESE SPAGNX2024-01-22
08033891327538CHORUS INFLUENZA B IgGDIESSE DIAGNOSTICA SENESE SPAGNX2024-01-22
00848838063701Remel REMEL, INC.GNX2021-11-12
30848838063702Remel REMEL, INC.GNX2021-11-12
03848838063708Remel REMEL, INC.GNX2021-11-12
00816917022925Poly statPOLYMEDCO, INC.GNX2019-04-18
30014613331469QuickVueQUIDEL CORPORATIONGNX2019-04-17
30014613003175QuickVueQUIDEL CORPORATIONGNX2019-03-21
30014613201830QuickVueQUIDEL CORPORATIONGNX2018-11-10
30014613202189SofiaQUIDEL CORPORATIONGNX2018-11-10
30014613202547SofiaQUIDEL CORPORATIONGNX2018-11-10
10743816001508Status Flu A+B cardPRINCETON BIOMEDITECH CORPORATIONGNX2018-07-05
00382902560708BD Veritor™ Plus Laboratory Combo PackBECTON, DICKINSON AND COMPANYGNX2018-05-25
00382902560739BD Veritor™ System Laboratory Combo PackBECTON, DICKINSON AND COMPANYGNX2018-05-25
00382902560746BD Veritor™ Plus CLIA-Waived Combo PackBECTON, DICKINSON AND COMPANYGNX2018-05-25
10743816001478BioSign Flu A+B cardPRINCETON BIOMEDITECH CORPORATIONGNX2018-04-09
10743816001447Status Flu A & BPRINCETON BIOMEDITECH CORPORATIONGNX2017-10-13
20612479225118McKessonMCKESSON MEDICAL-SURGICAL INC.GNX2017-09-29
20612479226795McKessonMCKESSON MEDICAL-SURGICAL INC.GNX2017-09-29
10743816001430Status Flu A+B Validation KitPRINCETON BIOMEDITECH CORPORATIONGNX2017-05-10
10743816001416Status Flu A+B Nasal Wash/Aspirate KitPRINCETON BIOMEDITECH CORPORATIONGNX2017-04-20
00382902560418BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kitBECTON, DICKINSON AND COMPANYGNX2017-02-02
00382902560456BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kitBECTON, DICKINSON AND COMPANYGNX2017-02-02