FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040019771
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1126219
Catalog number
1126219
Device description
Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimens
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10304040019778PackageGS127In Commercial Distribution
00304040019771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404001977810304040019778
00304040019771003040400197713040400197710304040019771

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
Special Storage Condition, Specify00No
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
012430880
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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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