Binax, Inc.
United StatesFDA applicant, unverified
- Devices
- 30
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Binax, Inc. makes
Binax, Inc. manufactures rapid diagnostic tests for infectious diseases, including respiratory and urinary antigen detection kits. Products target pathogens such as *Streptococcus pneumoniae*, *Respiratory Syncytial Virus (RSV)*, *Staphylococcus aureus*, *Influenza A & B*, and *Legionella*. Some tests are designed for point-of-care use with nasal swabs, while others detect urinary antigens. The portfolio also includes control kits and modified versions of existing tests for specific applications.
The company’s devices are classified under Class I and Class II regulatory categories in the US. Products are listed via 510(k) clearance with the FDA. The manufacturer is based in the United States.
Catalogue
Search and filter all 30 devicesFDA recalls
FDA recall records list 3 recalls initiated by Binax, Inc., initiated on 2004-02-18. By recorded status: 3 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 18 Feb 2004 Z-0778-04 Unclassified (pre-2012) Terminated Pouch integrity compromised
Full distribution text
- 18 Feb 2004 Z-0779-04 Unclassified (pre-2012) Terminated Pouch integrity compromised
Full distribution text
- 18 Feb 2004 Z-0780-04 Unclassified (pre-2012) Terminated Pouch integrity compromised
Full distribution text
- 18 Feb 2004 Z-0778-04 Unclassified (pre-2012) Terminated Pouch integrity compromised
Frequently asked questions
How many devices does Binax, Inc. have in the registry?
The registry currently lists 30 devices for Binax, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Binax, Inc.'s devices?
Among its 30 most recently registered devices, Binax, Inc. has devices listed in FDA 510(k) (30 devices).
What risk classes do Binax, Inc.'s devices fall under?
Among its 30 most recently registered devices, the classes recorded for Binax, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Binax, Inc.?
FDA recall records list 3 recalls initiated by Binax, Inc., the most recent initiated on 2004-02-18. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Binax, Inc. in the registry?
The most recently registered devices listed for Binax, Inc. include BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST, BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065, BINAXNOW PBP2A TEST, MODEL 890-000 and BINAX EQUATE STREP B.