Home GUDID 30810107290041 Flowflex Plus COVID-19 and Flu A/B Home Test
Primary DI 30810107290041
Brand Flowflex Plus COVID-19 and Flu A/B Home Test
Company ACON LABORATORIES, INC.
Model L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
Catalog number L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
Device description 1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Published 2024-08-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
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 00810107290019 Package GS1 1 In Commercial Distribution 00810107290026 Package GS1 2 In Commercial Distribution 00810107290033 Package GS1 5 In Commercial Distribution 00810107290040 Package GS1 25 In Commercial Distribution 10810107290016 Package GS1 12 In Commercial Distribution 10810107290023 Package GS1 12 In Commercial Distribution 10810107290030 Package GS1 12 In Commercial Distribution 20810107290013 Package GS1 24 In Commercial Distribution 20810107290020 Package GS1 18 In Commercial Distribution 20810107290037 Package GS1 8 In Commercial Distribution 30810107290010 Package GS1 300 In Commercial Distribution 30810107290027 Package GS1 210 In Commercial Distribution 30810107290034 Package GS1 120 In Commercial Distribution 30810107290041 Package GS1 24 In Commercial Distribution 40810107290017 Package GS1 6 In Commercial Distribution 40810107290024 Package GS1 6 In Commercial Distribution 40810107290031 Package GS1 6 In Commercial Distribution 50810107290014 Package GS1 8 In Commercial Distribution 50810107290021 Package GS1 8 In Commercial Distribution 50810107290038 Package GS1 6 In Commercial Distribution 60810107290011 Package GS1 48 In Commercial Distribution 60810107290028 Package GS1 48 In Commercial Distribution 60810107290035 Package GS1 36 In Commercial Distribution 70810107290032 Package GS1 10 In Commercial Distribution 80810107290015 Package GS1 252 In Commercial Distribution 80810107290039 Package GS1 8 In Commercial Distribution 00810107290002 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 00810107290019 00810107290019 810107290019 0810107290019 00810107290026 00810107290026 810107290026 0810107290026 00810107290033 00810107290033 810107290033 0810107290033 00810107290040 00810107290040 810107290040 0810107290040 10810107290016 10810107290016 10810107290023 10810107290023 10810107290030 10810107290030 20810107290013 20810107290013 20810107290020 20810107290020 20810107290037 20810107290037 30810107290010 30810107290010 30810107290027 30810107290027 30810107290034 30810107290034 30810107290041 30810107290041 40810107290017 40810107290017 40810107290024 40810107290024 40810107290031 40810107290031 50810107290014 50810107290014 50810107290021 50810107290021 50810107290038 50810107290038 60810107290011 60810107290011 60810107290028 60810107290028 60810107290035 60810107290035 70810107290032 70810107290032 80810107290015 80810107290015 80810107290039 80810107290039 00810107290002 00810107290002 810107290002 0810107290002
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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
Regulatory Flags# DUNS number 781100966 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00682607551354 ON CALL® SURE BLOOD GLUCOSE STRIPS OGS-211 G135-20U-101 2026-07-31 00682607551361 ON CALL® SURE BLOOD GLUCOSE STRIPS OGS-211 G135-20U-104 2026-07-31 00682607551378 ON CALL® SURE BLOOD GLUCOSE STRIPS OGS-211 G135-20U-105 2026-07-31 00682607815234 ON CALL® SURE BLOOD KETONE STRIPS OGS-511 GK135-201-101 2026-07-31 00682607815241 ON CALL® SURE BLOOD KETONE STRIPS OGS-511 GK135-201-102 2026-07-31 00682607815258 ON CALL® SURE BLOOD KETONE STRIPS OGS-511 GK135-201-104 2026-07-31 00682607815265 ON CALL® SURE BLOOD KETONE STRIPS OGS-511 GK135-201-105 2026-07-31 00682607551385 ON CALL® SURE BLOOD CONTROL SOLUTION OGS-211 G125-22U-101 2026-07-30 00682607551392 ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEM OGM-211 G115-20U-101 2026-07-30 00682607551408 ON CALL® SURE BLOOD GLUCOSE METER OGM-211 G115-21U-101 2026-07-30 00682607551422 ON CALL® SURE BLOOD GLUCOSE METER OGM-211 G115-22U-101 2026-07-30 00682607551439 ON CALL® SURE BLOOD GLUCOSE METER OGM-211 G115-23U-101 2026-07-30 00682607551446 ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEM OGM-212 G115-20W-101 2026-07-30 00682607551453 ON CALL® SURE SYNC BLOOD GLUCOSE METER OGM-212 G115-21W-101 2026-07-30 00682607551460 ON CALL® SURE SYNC BLOOD GLUCOSE METER OGM-212 G115-22W-101 2026-07-30 00682607551477 ON CALL® SURE SYNC BLOOD GLUCOSE METER OGM-212 G115-23W-101 2026-07-30 00682607815098 ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM OGM-511 GK115-201-101 2026-07-30 00682607815104 ON CALL® SURE GK BLOOD GLUCOSE & KETONE METER OGM-511 GK115-221-101 2026-07-30 00682607815111 ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM OGM-512 GK115-222-101 2026-07-30 00682607815272 ON CALL® SURE KETONE CONTROL SOLUTION OGC-511 GK125-221-101 2026-07-30
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