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Flowflex Plus COVID-19 + Flu A/B Home Test

Acon Laboratories, Inc. · Model L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945 · UDI-DI 00810107290002

SCA
10
510(k) clearances
51
Adverse events
0
Recalls
26
Facilities

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)

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.