Binax, Inc.
Medical device manufacturer in Scarborough, ME.
30510(k) clearances
0PMA approvals
0recalls
Device types
- GTZ Antisera, All Groups, Streptococcus Spp. 6
- PSZ Devices Detecting Influenza A, B, And C… 6
- LCP Assay, Glycosylated Hemoglobin 2
- MJH Legionella, Spp., Elisa 2
- GQG Antigen, Cf (Including Cf Controls)… 2
- MYI System, Test, Genotypic Detection… 2
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- CFT Radioimmunoassay, Prolactin (Lactogen) 1
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
- JIT Calibrator, Secondary 1
- DFC Lipoprotein, Low-Density, Antigen… 1
- JBF Glucose-6-Phosphate Dehydrogenase… 1
- MJZ Kit, Direct Antigen, Positive Control 1
- GTY Antigens, All Groups, Streptococcus Spp. 1
- JWX Kit, Screening, Staphylococcus Aureus 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K090301 | Binaxnow PBP2A Test, Model 890-000MYI · Traditional | 04/14/2010SE |
| K091766 | Clearview Exact PBP2A Test, Model 891-000MYI · Traditional | 02/24/2010SE |
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | 12/16/2009SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | 09/04/2009SE |
| K083744 | Binaxnow Malaria Positive Control Kit, Model 665-010MJZ · Traditional | 09/01/2009SE |
| K092223 | Modification to: Binaxnow Influenza a & B TestPSZ · Special | 08/12/2009SE |
| K080003 | Binaxnow G6PD TestJBF · Traditional | 10/23/2008SE |
| K062109 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/09/2006SE |
| K053126 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/30/2005SE |
| K041049 | Binaxnow Influenza a & B TestPSZ · Traditional | 08/10/2004SE |
| K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…GQG · Traditional | 10/21/2003SE |
| K021649 | Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory PackPSZ · Traditional | 09/19/2002SE |
| K021646 | Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory PackPSZ · Traditional | 09/19/2002SE |
| K021687 | Binax Now RSV Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accessory PackGQG · Traditional | 09/13/2002SE |
| K012521 | Binax Now Streptococcus Pneumoniae TestGTZ · Traditional | 11/30/2001SE |
| K010523 | Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen TestGTZ · Special | 03/15/2001SE |
| K991726 | Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test KIT),(12 Test Kit)…GTZ · Traditional | 08/27/1999SE |
| K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella…MJH · Traditional | 08/21/1998SE |
| K960712 | Binax Strep a TestGTZ · Traditional | 03/22/1996SE |
| K934965 | Binax Legionella Urinary Antigen EiaMJH · Traditional | 09/20/1994SE |
| K912748 | Binax Equate(R) Glycohemoglobin 3 Minute Test KitLCP · Traditional | 10/31/1991SE |
| K903122 | Equate(Tm) Aqr Apo Al/B Duo ControlDFC · Traditional | 08/02/1990SE |
| K883306 | Binas Luteinizing Hormone Irma Test KitJIT · Traditional | 10/06/1988SE |
| K883305 | Binax FSH Irma Test Kit, Immunoradiometric AssayCGJ · Traditional | 10/06/1988SE |
| K874749 | Binax Equate GlycohemoglobinLCP · Traditional | 08/12/1988SE |
| K880218 | Binax Prolactin Irma Diagnostic KitCFT · Traditional | 03/01/1988SE |
| K872904 | Binax Equate Strep BGTZ · Traditional | 11/20/1987SE |
| K873303 | Binax L.S. TSH Irma Test KitJLW · Traditional | 10/02/1987SE |
| K872728 | Binax Irma Total Beta-Hcg Test KitJHI · Traditional | 08/05/1987SE |
| K863908 | Binax Strep aGTZ · Traditional | 12/22/1986SE |