Home GUDID 00816917022925 Poly stat
Primary DI 00816917022925
Brand Poly stat
Company POLYMEDCO, INC.
Model FLU25
Device description Flu A & B, Immunochromatographic, 25 Test Kit
Published 2019-04-18
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 Code Name GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816917022925 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816917022925 00816917022925 816917022925 0816917022925
GMDN Terms# Term, Definition table Term Definition Influenza A/B virus neuraminidase activity IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi quantitative detection of neuraminidase activity specific to 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 024798555 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 16977977230024 N/A Zhengzhou Shiyi Biotech Co., Ltd. GNX 2025-01-28 16977977230031 N/A Zhengzhou Shiyi Biotech Co., Ltd. GNX 2025-01-28 26977977230021 N/A Zhengzhou Shiyi Biotech Co., Ltd. GNX 2025-01-28 26977977230038 N/A Zhengzhou Shiyi Biotech Co., Ltd. GNX 2025-01-28 05032384502981 IMAGEN Influenza Virus A and B OXOID LIMITED GNX 2024-12-30 00855113008722 ClearFit LONGEVITI NEURO SOLUTIONS LLC GNX 2024-03-20 00855113008661 Longeviti Convenience Kit 5.0 LONGEVITI NEURO SOLUTIONS LLC GNX 2024-03-15 08033891327514 CHORUS INFLUENZA A IgG DIESSE DIAGNOSTICA SENESE SPA GNX 2024-01-22 08033891327538 CHORUS INFLUENZA B IgG DIESSE DIAGNOSTICA SENESE SPA GNX 2024-01-22 00848838063701 Remel REMEL, INC. GNX 2021-11-12 30848838063702 Remel REMEL, INC. GNX 2021-11-12 03848838063708 Remel REMEL, INC. GNX 2021-11-12 30014613331469 QuickVue QUIDEL CORPORATION GNX 2019-04-17 30014613003175 QuickVue QUIDEL CORPORATION GNX 2019-03-21 30014613201830 QuickVue QUIDEL CORPORATION GNX 2018-11-10 30014613202189 Sofia QUIDEL CORPORATION GNX 2018-11-10 30014613202547 Sofia QUIDEL CORPORATION GNX 2018-11-10 10743816001508 Status Flu A+B card PRINCETON BIOMEDITECH CORPORATION GNX 2018-07-05 00382902560708 BD Veritor™ Plus Laboratory Combo Pack BECTON, DICKINSON AND COMPANY GNX 2018-05-25 00382902560739 BD Veritor™ System Laboratory Combo Pack BECTON, DICKINSON AND COMPANY GNX 2018-05-25 00382902560746 BD Veritor™ Plus CLIA-Waived Combo Pack BECTON, DICKINSON AND COMPANY GNX 2018-05-25 10743816001478 BioSign Flu A+B card PRINCETON BIOMEDITECH CORPORATION GNX 2018-04-09 10743816001447 Status Flu A & B PRINCETON BIOMEDITECH CORPORATION GNX 2017-10-13 20612479225118 McKesson MCKESSON MEDICAL-SURGICAL INC. GNX 2017-09-29 20612479226795 McKesson MCKESSON MEDICAL-SURGICAL INC. GNX 2017-09-29 10743816001430 Status Flu A+B Validation Kit PRINCETON BIOMEDITECH CORPORATION GNX 2017-05-10 10743816001416 Status Flu A+B Nasal Wash/Aspirate Kit PRINCETON BIOMEDITECH CORPORATION GNX 2017-04-20 00382902560418 BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit BECTON, DICKINSON AND COMPANY GNX 2017-02-02 00382902560456 BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit BECTON, DICKINSON AND COMPANY GNX 2017-02-02 00742860100215 OSOM Ultra Flu A&B Controls 5 Test SEKISUI DIAGNOSTICS, LLC GNX 2017-01-10