The following data is part of a premarket notification filed by Trinity Biotech Usa with the FDA for Captia Hsv 2 Igg Type Specific Elisa Kit.
| Device ID | K033106 |
| 510k Number | K033106 |
| Device Name: | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Applicant | TRINITY BIOTECH USA 2823 GIRTS RD. Jamestown, NY 14701 |
| Contact | Bonnie B Dejoy |
| Correspondent | Bonnie B Dejoy TRINITY BIOTECH USA 2823 GIRTS RD. Jamestown, NY 14701 |
| Product Code | MYF |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746939 | K033106 | 000 |
| 05391516743327 | K033106 | 000 |