| WOUNDCHEK Bacterial Status (DEN180014) | Alere Scarborough, Inc. | 2019-12-02 |
| ID NOW Influenza A & B 2 (K190204) | Alere Scarborough, Inc. | 2019-03-18 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader (K181853) | Alere Scarborough, Inc. | 2018-08-08 |
| Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (K173653) | Alere Scarborough, Inc. | 2018-05-02 |
| Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (K173932) | Alere Scarborough, Inc. | 2018-01-26 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K173502) | Alere Scarborough, Inc. | 2017-12-13 |
| Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K171792) | Alere Scarborough, Inc. | 2017-09-29 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K162642) | Alere Scarborough, Inc. | 2017-04-10 |
| Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (K163266) | Alere Scarborough, Inc. | 2016-12-21 |
| Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (K161375) | Alere Scarborough, Inc. | 2016-08-18 |
| BinaxNOW G6PD Test (K161364) | Alere Scarborough, Inc. | 2016-06-17 |
| Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K151464) | Alere Scarborough, Inc. | 2015-07-28 |
| Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (K151690) | Alere Scarborough, Inc. | 2015-07-16 |
| ALERE I STREP A (K141757) | Alere Scarborough, Inc. | 2015-03-31 |
| ALERE PBP2A SA/CONS CULTURE COLONY TEST (K133851) | Alere Scarborough, Inc. | 2014-09-03 |
| ACTIM PROM (K123986) | Alere Scarborough, Inc. | 2014-01-09 |
| ALERE PBP2A TEST (K121905) | Alere Scarborough, Inc. | 2012-07-26 |