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