| Certificate Authority |
|
Certificate |
|
No. of certificate |
|
|
|
|
|
| Korea Food & Drug Administration (KFDA) |
|
Certificate of Pharmaceutical Manufacturing License |
|
314 |
|
|
|
|
|
| SGS |
|
ISO 13485:2003, EN ISO 13485:2012
: HPV(Human Papilloma virus) genotyping kit & PNA Clamping Kit & PANA qPCR Kit |
|
KR10/01433 |
|
|
|
|
|
| SGS |
|
ISO 9001:2008
: PNA, HPV(Human Papilloma virus) genotyping kit, PNA Clamping Kit, PANA qPCR Kit |
|
KR10/01432 |
|
|
|
|
|
| Korea Food & Drug Administration (KFDA) |
|
Certificate of Manufacturer : IVD reagents for cancer related gene |
|
4011 |
|
|
|
|
|
| Korea Food & Drug Administration (KFDA) |
|
Certificate of Free Sales : PNAClamp¢â BRAF Mutation Detection Kit |
|
13-27 |
|
|
|
|
|
| Korea Food & Drug Administration (KFDA) |
|
Certificate of Free Sales : PNAClamp¢â EGFR Mutation Detection Kit |
|
13-28 |
|
|
|
|
|
| Korea Food & Drug Administration (KFDA) |
|
Certificate of Free Sales : PNAClamp¢â KRAS Mutation Detection Kit |
|
13-29 |
|
|
|
|
|
| Ministry of Food and Drug Safety(MFDS) |
|
Certificate of Free Sales : PNAClamp¢â IDH1 Mutation Detection Kit |
|
13-1070 |
|
|
|
|
|
| Ministry of Food and Drug Safety(MFDS) |
|
Certificate of Free Sales : PANA qPCR¢â TB/NTM Detection Kit |
|
13-612 |
|
|
|
|
|
| Ministry of Food and Drug Safety(MFDS) |
|
Certificate of Free Sales : PNAClamp¢â Mutation Detection Kit
[KRAS (Ver. 3), EGFR (Ver. 2), PIK3CA] |
|
13-1626,
13-1627,
13-1677 |
|
|
|
|
|
| Ministry of Food and Drug Safety(MFDS) |
|
Certificate of Pharmaceutical Product : PANArray¢â HPV Genotyping Chip (Ver. 2) |
|
593 |
|
|
|
|
|
| Ministry of Food and Drug Safety(MFDS), Korea Testing & Research Institute(KTR) |
|
Certificate of GMP |
|
KTR-AAB-130586 |
|
|
|
|
|
| Ministry of Food and Drug Safety(MFDS) |
|
Certificate of Free Sales : PNAClamp¢â NRAS Mutation Detection Kit |
|
16-568 |
|
|
|
|
|
|
|
|
|
|
