CORETESTS, INC.
2 clearances
Scorecard
Events per device across the 31-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
31 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| CorDx Tyfast | ACT21001-25 | QMN | 00850042559635 | 2 |
| ACCU NEWS Multi-Drug Screen Test | Multi-panel | DIO DJC DJG DKZ LDJ | 00850042559024 | 1 |
| ACCU NEWS Ovulation Test + Pregnancy Test Combo | strip | LCX NGE | 00850042559017 | 1 |
| ACCU NEWS Pregnancy Test Midstream | Midstream | LCX | 00850042559000 | 1 |
| CorDx Tyfast | ACT21003-12 | QYT | 00850042559956 | 1 |
| CorDx Tyfast | ACT21003-8 | QYT | 00850042559932 | 1 |
| CorDx Tyfast | ACT21003-2B | QYT | 00850042559673 | 1 |
| CorDx Tyfast | ACT21003-10 | QYT | 00850042559949 | 1 |
| CorDx Tyfast | ACT21003-5 | QYT | 00850042559925 | 1 |
| CorDx Tyfast | ACT21003-4 | QYT | 00850042559918 | 1 |
| CorDx Tyfast | ACT21003-2A | QYT | 00850042559666 | 1 |
| CorDx Tyfast | ACT21003-20 | QYT | 00850042559963 | 1 |
| CorDx | CO291-10 | QKP | 00850042559093 | 0 |
| CorDx | CO291-2 | QKP | 00850042559079 | 0 |
| CorDx | CO291-5 | QKP | 00850042559086 | 0 |
| CorDx | CO291-2 | QKP | 00850042559123 | 0 |
| CorDx | CO291-8 | QKP | 00850042559154 | 0 |
| CorDx | CO291-10 | QKP | 00850042559147 | 0 |
| CorDx | CO291-5 | QKP | 00850042559130 | 0 |
| CorDx Tyfast | ACT21002-5 | QMN | 00850042559536 | 0 |
| CorDx Tyfast | ACT21006-3 | LCX | 00850042559819 | 0 |
| CorDx Tyfast | ACT21012-3 | LCX | 00850042559765 | 0 |
| CorDx Tyfast | ACT21014-21 | NGE | 00850042559888 | 0 |
| CorDx Tyfast | ACT21001-10 | QMN | 00850042559659 | 0 |
| CorDx Tyfast | ACT21002-4 | QMN | 00850042559567 | 0 |
| CorDx Tyfast | ACT21002-2 | QMN | 00850042559550 | 0 |
| CorDx Tyfast | ACT21002-1 | QMN | 00850042559529 | 0 |
| CorDx Tyfast | ACT21013 | LCX NGE | 00850042559772 | 0 |
| CorDx Tyfast | ACT21006-7 | LCX | 00850042559826 | 0 |
| CorDx Tyfast | ACT21006-21 | LCX | 00850042559833 | 0 |
Showing 1–30 of 31Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
No registered facilities linked.