FDA.reportPublic FDA data

Remel

Primary DI
00848838027031
Brand
Remel
Company
REMEL, INC.
Model
R24600
Device description
Xpect Flu A&B KT/20TST
Published
2021-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092423000XPECT FLU A & BThermo Fisher Scientific2009-08-26PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838027031PrimaryGS10
30848838027032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838027031008488380270318488380270310848838027031
3084883802703230848838027032

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.

Contacts#

Phone, Email table
PhoneEmail
8002556730csemail@thermofisher.com

Regulatory Flags#

DUNS number
065769564
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

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
30848838027032Remel REMEL, INC.PSZ2021-11-12
03848838027038Remel REMEL, INC.PSZ2021-11-12
10743816001553Status™ COVID-19/FluPRINCETON BIOMEDITECH CORPORATIONPSZ2021-02-15
00742860100390OSOM ULTRA PLUS FLU A&B Test SEKISUI 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