# Binax, Inc.

- Location (FDA's records): Portland, ME
- FDA decisions: 30 (1986–2010): 30 510(k) clearances
- Product codes: PSZ (6), GTZ (6), MJH (2), LCP (2), MYI (2), GQG (2), JIT (1), GTY (1), CGJ (1), MJZ (1), JWX (1), DFC (1)
- Predicates its devices cite: 25 (7 its own); citations of its devices by later devices: 28 (7 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Quidel Corp.: 3 (https://510kreport.com/company/quidel)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Remel Co.: 2 (https://510kreport.com/company/remel)
- Oxoid, Ltd.: 2 (https://510kreport.com/company/oxoid)
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Wellcome Diagnostics: 2 (https://510kreport.com/company/wellcome-diagnostics)
- Wyntek Diagnostics, Inc.: 1 (https://510kreport.com/company/wyntek-diagnostics)
- Advandx, Inc.: 1 (https://510kreport.com/company/advandx)

## Firms that cite its devices most
- Meridian Bioscience, Inc.: 5 (https://510kreport.com/company/meridian-bioscience)
- Ssi Diagnostica A/S: 3 (https://510kreport.com/company/ssi-diagnostica-a-s)
- Alere Scarborough, Inc.: 2 (https://510kreport.com/company/alere-scarborough)
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Sa Scientific, Inc.: 2 (https://510kreport.com/company/sa-scientific)
- Alere Scarborough, Inc D/B/A Binax, Inc.: 1 (https://510kreport.com/company/alere-scarborough-d-b-a-binax)
- Inverness Medical, Inc.: 1 (https://510kreport.com/company/inverness-medical)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)

## Its most-cited devices
- K021649: Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack (2002), cited by 5
- K062109: Binaxnow Influenza a & B Test (2006), cited by 4
- K021646: Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack (2002), cited by 3
- K982238: Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522 (1998), cited by 3
- K091766: Clearview Exact PBP2A Test, Model 891-000 (2010), cited by 2
- K032166: Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065 (2003), cited by 2

## Recent decisions
- K090301: Binaxnow PBP2A Test, Model 890-000 (Apr 14, 2010)
- K091766: Clearview Exact PBP2A Test, Model 891-000 (Feb 24, 2010)
- K090964: Binaxnox Staphylococcus Aureus Test (Dec 16, 2009)
- K091489: Clearview Advanced Strep a , Model 737-430 (Sep 4, 2009)
- K083744: Binaxnow Malaria Positive Control Kit, Model 665-010 (Sep 1, 2009)
- K092223: Modification to: Binaxnow Influenza  a & B Test (Aug 12, 2009)
- K080003: Binaxnow G6PD Test (Oct 23, 2008)
- K062109: Binaxnow Influenza a & B Test (Nov 9, 2006)

Source page: https://510kreport.com/company/binax