FDA.reportPublic FDA data

OSOM Ultra Flu A&B 25T Kit

Primary DI
00742860100222
Brand
OSOM Ultra Flu A&B 25T Kit
Company
Sekisui Diagnostics, LLC
Model
1006
Catalog number
1006
Device description
OSOM Ultra Flu A&B 25T Kit
Published
2017-01-10
Public version status
Update
Distribution status
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
PSZDevices detecting influenza A, B, and C virus antigens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00742860100222PrimaryGS10
10742860100229Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00742860100222007428601002227428601002220742860100222
1074286010022910742860100229

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

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
00695684744250AimStep Flu A&B Test KitGERMAINE LABORATORIES, INCPSZ2026-05-11
06970640093097INNOVITAInnovita (Tangshan) Biological Technology Co., Ltd.PSZ2026-04-15
00742860100413Acucy Printer PaperSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
10742860100410Acucy Printer PaperSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00742860100444Acucy Reader A/C AdapterSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00742860100475Acucy System Universal DrawerSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONPSZ2024-08-08
20885380200844CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
50885380200845CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
00850056728706ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen TestLumos Diagnostics, Inc.PSZ2023-11-30
00848838027031Remel REMEL, INC.PSZ2021-11-12
30848838027032Remel REMEL, INC.PSZ2021-11-12
03848838027038Remel REMEL, INC.PSZ2021-11-12
00742860100390OSOM ULTRA PLUS FLU A&B TestSekisui Diagnostics, LLCPSZ2020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control KitSekisui Diagnostics, LLCPSZ2020-06-01
10742860100397OSOM ULTRA PLUS FLU A&B Test SEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
00742860100338Acucy SystemSEKISUI DIAGNOSTICS, LLCPSZ2019-09-24
00742860100345Acucy Calibration DeviceSekisui Diagnostics, LLCPSZ2019-09-24
00742860100383Acucy Influenza A&B Control KitSEKISUI DIAGNOSTICS, LLCPSZ2019-08-23
00742860100376Acucy Flu Test KitSEKISUI DIAGNOSTICS, LLCPSZ2019-08-20
10811877010972BinaxNOW Influenza A & B Card 2Alere Scarborough, Inc.PSZ2019-07-15
10811877010989BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.PSZ2019-07-15
00895160002526Fluoro-CheckTM Influenza A+BNANO-DITECH CORPORATIONPSZ2019-05-24
10811877010422ID NOW Influenza A & B 2Alere Scarborough, Inc.PSZ2018-10-29
10811877010439ID NOW Influenza A & B Control Swab KitAlere Scarborough, Inc.PSZ2018-10-29
10854916006796MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PSZ2018-07-30
10854916006802MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PSZ2018-07-30
00382902560715BD Veritor™ System CLIA-Waived Combo PackBECTON, DICKINSON AND COMPANYPSZ2018-05-25
00840733101649ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate KitMERIDIAN BIOSCIENCE, INC.PSZ2018-03-12
00840733101656ImmunoCard STAT! FLU A&BMERIDIAN BIOSCIENCE, INC.PSZ2018-03-12