Address
6F.-3, No.371, Sec. 1, Guangfu Rd., East Dist., Hsinchu City 30074, Taiwan (R.O.C.)
Contact
Tel：+886-3-666-0139
Fax：+886-3-666-0149
Email: services@seqpro.com.tw
Successful Product Registration (IVD Devices)
| Regulation Number – Class – Number of Cases |
|---|
| 1. B.4020 Analyte specific reagents (Class 3) · 3 Cases |
| 2. A.1050 Alkaline phosphatase or isoenzymes test system (Class 2) · 1 Case |
| 3. A.1070 Amylase test system (Class 2) · 1 Case |
| 4. A.1110 Bilirubin (total or direct) test system (Class 2) · 1 Case |
| 5. A.1145 Calcium test system (Class 2) · 1 Case |
| 6. A.1150 Calibrator (Class 2) · 16 Cases |
| 7. A.1225 Creatinine test system (Class 2) · 1 Case |
| 8. A.1235 Cyclosporine test system (Class 2) · 1 Case |
| 9. A.1295 Folic acid test system (Class 2) · 1 Case |
| 10. A.1340 Urinary glucose (nonquantitative) test system (Class 2) · 2 Cases |
| 11. A.1377 Urinary homocystine (nonquantitative) test system (Class 2) · 1 Case |
| 12. A.1660 Quality control material (assayed and unassayed) (Class 2) · 4 Cases |
| 13. A.1678 Tacrolimus test system (Class 2) · 1 Case |
| 14. A.1690 Thyroid stimulating hormone test system (Class 2) · 1 Case |
| 15. A.1810 Vitamin B12 test system (Class 2) · 1 Case |
| 16. A.3150 Barbiturate test system (Class 2) · 1 Case |
| 17. A.3170 Benzodiazepine test system (Class 2) · 1 Case |
| 18. A.3650 Opium test system (Class 2) · 1 Case |
| 19. A.3870 Cannabinoid test system (Class 2) · 1 Case |
| 20. B.5260 Automated cell-locating device (Class 2) · 1 Case |
| 21. B.7250 Erythropoietin assay (Class 2) · 1 Case |
| 22. C.3175 Cytomegalovirus serological reagents (Class 2) · 1 Case |
| 23. C.3210 Endotoxin assay (Class 2) · 2 Cases |
| 24. C.5270 C-reactive protein immunological test system (Class 2) · 1 Case |
| 25. C.5550 Immunoglobulin (light chain specific) immunological test system (Class 2) · 1 Case |
| 26. C.5580 α-1-lipoprotein immunological test system (Class 2) · 1 Case |
| 27. C.5680 Myoglobin immunological test system (Class 2) · 1 Case |
| 28. C.5750 Radioallergosorbent (RAST) immunological test system (Class 2) · 6 Cases |
| 29. C.5870 Thyroid autoantibody immunological test system (Class 2) · 1 Case |
| 30. E.1425 Programmable diagnostic computer (Class 2) · 2 Cases |
| 31. P.1600 Angiographic x-ray system (Class 2) · 10 Cases |
| 32. P.1650 Image-intensified fluoroscopic x-ray system (Class 2) · 5 Cases |
| 33. P.1680 Stationary x-ray system (Class 2) · 2 Cases |
| 34. P.1710 Mammographic x-ray system (Class 2) · 2 Cases |
| 35. P.2050 Picture archiving and communication system (Class 2) · 2 Cases |
| 36. A.1240 Cystine test system (Class 1) · 1 Case |
| 37. A.1260 Estradiol test system (Class 1) · 1 Case |
| 38. A.1265 Estriol test system (Class 1) · 1 Case |
| 39. A.1370 Human growth hormone test system (Class 1) · 1 Case |
| 40. A.1475 Lipoprotein test system (Class 1) · 1 Case |
| 41. A.1625 Prolactin (lactogen) test system (Class 1) · 1 Case |
| 42. A.170 Triglyceride test system (Class 1) · 2 Cases |
| 43. A.2160 Discrete photometric chemistry analyzer for clinical use (Class 1) · 1 Case |