| Manufacturer and original inventor |
EY Laboratories, Inc. |
| Test concept |
Direct Flow Through |
| ISO 13485 |
Yes |
| procedural control |
Yes |
| biological control |
Yes |
| multiple washes |
Not needed |
| volume of sample |
50ul |
| incubation periods |
Not needed |
| electrical supply |
Not needed |
| Timer required |
Not needed |
| maintaining “cold chain” |
Not required |
| Point of care potential |
High |
| Positive result |
Red dot + control dot (for CD tests only) |
| Negative result |
0 dots + control dot (for CD tests only) |
| Test Run Time |
60 Seconds or less |
| Device Size |
approx 1.5″ x 1.5″ x 0.25″ |
| Controls? |
Included |
| Reagents |
Lyophilized, included |
| Shelf life |
12 – 15months |
| Storage Conditions |
-18 to 26 degrees Celsius |
| Controls Included? |
Yes |
| Device Control? |
Yes |
| Instruction booklet |
Yes |
| *Specifications may vary depending on type of kit |
