FDA 510K Cleared Tests

Parallax’s Target System platform currently has five infectious disease tests that were cleared by the FDA as well as an FDA 510K cleared desktop analyzer.

Parallax is developing a wireless, hand-held analyzer that is based on a re-engineering of the Company’s desktop analyzer. A patent is currently pending on utilization of the hand-held analyzer with the Micro-Flow Through technology. 

Infectious Disease & Pregnancy

Rotacube (Rotavirus)K884017
Rubella-Cube TMK892051
Cmv-Cube TMK884842
Blue Dot Test for PregnancyK884017
First Sign (Pregnancy, Hcg)K973208
V-Trend Target Im Test (infect mononucleosis)K890041
Target Strep A (Streptococcus Spp.)K880460
Target Aso Test K910073
Target HcgK914303
Target Quantitative Hog One StepK903937
V-Trend Target Rf TestK904105
Target Quantitative HcgK890131

Drugs of Abuse

Target Cocaine MetabolitesK910122
Target Cocaine MetabolitesK910123
Target CannabinoidsK910893
Target CannabinoidsK910892
Target Amphetamines MethamphetaminesK910739
Target OpiateK89097
Target OpiateK890979

Cardiac Markers

Target Cardiac Ck-MbK890295
Target Cardiac Troponin-IK972094
Target Cardiac C-reactive protein TestK892231
Target Cardiac C-reactive protein TestK890423
Target Myoglobin TestK963680

Target Quantitative Reader

Target Quantitative ReaderK885254