CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT

Device Classification Name

enzyme linked immunosorbent assay, herpes simplex virus, hsv-2

510(k) Number K033106
Device Name CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
Applicant
TRINITY BIOTECH USA
2823 girts rd.
jamestown, 
NY 
14701

Applicant Contact bonnie b dejoy
Correspondent
TRINITY BIOTECH USA
2823 girts rd.
jamestown, 
NY 
14701

Correspodent Contact bonnie b dejoy
Regulation Number 866.3305
Classification Product Code
MYF  
Date Received 09/30/2003
Decision Date 07/13/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No