FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066003343
Brand
Rapid Response
Company
BTNX Inc
Model
FLUab-19C15
Catalog number
FLUab-19C15
Device description
Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of Influenza A and B Virus Antigens in nasal specimens.
Published
2016-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041441000SAS INFLUENZA A TESTSa Scientific, Inc.2004-07-22PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00722066003343PrimaryGS10
00722066004241Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00722066003343007220660033437220660033430722066003343
00722066004241007220660042417220660042410722066004241

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus antigen IVD, kit, immunochromatographic test (ICT), rapidA 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. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251005005
Device count
15
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066015053Rapid ResponseD12.49-1VAF2026-05-15
10722066015084Rapid ResponseD13.5-1VF2026-05-15
10722066011260Rapid ResponseD13.5-1VF2026-01-19
10722066011277Rapid ResponseD12.49-1VAF2026-01-19
20722066011267Rapid ResponseD13.5-1VF2026-01-19
20722066011274Rapid ResponseD12.49-1VAF2026-01-19
10722066011338Rapid ResponseFOB-9C36FOB-9C362026-01-02
20722066011335Rapid ResponseFOB-9C36FOB-9C362026-01-02
00722066000205Rapid ResponseHCG-3C50HCG-3C502016-10-25
00722066000267Rapid ResponseHCG-3C25HCG-3C252016-10-25
00722066004548Rapid ResponseD12.5-1V2019-01-21
10722066009083Rapid ResponseD12.49-1VA2025-10-03
10722066010973Rapid ResponseD13.5-1V2025-07-08
00722066010976Rapid ResponseD13.5-1V2025-07-08
10722066009601Rapid ResponseCOF-19CGHU22025-05-29
10722066009618Rapid ResponseCOF-19CGHU42025-05-29
10722066010751Rapid ResponseSTR-15SGPU-252025-05-29
10722066009595Rapid ResponseCOF-19CGHU12025-05-29
00722066009604Rapid ResponseCOF-19CGHU22025-05-29
00722066009611Rapid ResponseCOF-19CGHU42025-05-29

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