Home GUDID 00850044118458 iHealth
Primary DI 00850044118458
Brand iHealth
Company iHealth Labs Inc.
Model ICF-3000
Published 2024-05-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC 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 10850044118455 Package GS1 1 In Commercial Distribution 20850044118452 Package GS1 4 In Commercial Distribution 30850044118459 Package GS1 72 In Commercial Distribution 00850044118458 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 10850044118455 10850044118455 20850044118452 20850044118452 30850044118459 30850044118459 00850044118458 00850044118458 850044118458 0850044118458
GMDN Terms# Term, Definition table Term Definition Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
Regulatory Flags# DUNS number 054953337 Device count 1 Premarket exempt 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 10850044118462 iHealth iHealth Labs Inc. QMN 2026-07-14 20850044118445 iHealth iHealth Labs Inc. QMN 2026-07-14 00850044118441 iHealth iHealth Labs Inc. QMN 2026-07-14 00850044118465 iHealth iHealth Labs Inc. QMN 2026-07-14 20850044118650 iHealth iHealth Labs Inc. QMN 2026-05-15 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