Home GUDID 30014613339229 Sofia
Primary DI 30014613339229
Brand Sofia
Company QUIDEL CORPORATION
Model 20377
Catalog number 20377
Device description Sofia®2 Flu + SARS Antigen FIA
Published 2021-02-17
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 Code Name QMN COVID-19 Multi-Analyte Antigen Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QMN Covid-19 Multi-Analyte Antigen Device Unknown N
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50014613339223 Package GS1 12 In Commercial Distribution 30014613339229 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50014613339223 50014613339223 30014613339229 30014613339229
GMDN Terms# Term, Definition table Term Definition Multiple respiratory virus antigen IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple respiratory viruses in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses (e.g., SARS-CoV-2), enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 079509836 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 00850044118656 iHealth iHealth Labs Inc. QMN 2026-05-15 00816862026863 WELLlife™ WONDFO USA CO., LTD. QMN 2025-05-16 10816862026860 WELLlife™ WONDFO USA CO., LTD. QMN 2025-05-16 00816862026153 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-24 10816862026150 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-24 00816862024586 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 00816862024630 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 00816862024661 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 00816862024685 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 00816862024708 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 00816862024722 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 10816862024583 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 10816862024637 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 10816862024668 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 10816862024682 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 10816862024705 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 10816862024729 WELLlife™ WONDFO USA CO., LTD. QMN 2024-12-20 00816862024500 WELLlife™ WONDFO USA CO., LTD. QMN 2024-09-24 10816862024507 WELLlife™ WONDFO USA CO., LTD. QMN 2024-09-24 30810107290041 Flowflex Plus COVID-19 and Flu A/B Home Test ACON LABORATORIES, INC. QMN 2024-08-14 00850042559536 CorDx Tyfast CORETESTS, INC. QMN 2024-06-13 00850042559550 CorDx Tyfast CORETESTS, INC. QMN 2024-06-13 00850042559567 CorDx Tyfast CORETESTS, INC. QMN 2024-06-13 00850042559529 CorDx Tyfast CORETESTS, INC. QMN 2024-06-13 10850042559533 CorDx Tyfast CORETESTS, INC. QMN 2024-06-13 10850042559557 CorDx Tyfast CORETESTS, INC. QMN 2024-06-13 10850042559564 CorDx Tyfast CORETESTS, INC. QMN 2024-06-13 00850044118427 iHealth iHealth Labs Inc. QMN 2024-05-25 00850044118434 iHealth iHealth Labs Inc. QMN 2024-05-24 00850044118458 iHealth iHealth Labs Inc. QMN 2024-05-24
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