[Company Information]

l Name : NanoEnTek

l Website Address : http://www.nanoentek.com

l Location

- Headquarters: 12F, 5, Digital-ro 26-gil, Guro-gu, Seoul, 152-740, Korea Tel : +82-2-6220-7942 / Fax : +82-2-6220-7999

- Manufacturing Plants 1: 851-14, Seohae-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, 445-917, Korea

l Contacts Department

- Contacts: IVD Division (E-mail :ivdis@nanoentek.com)

l Manufacturer Information : Refer to the attached file

[Medical Device Information]

l Product 1

- Name : FREND^TM System

- Intended Use : FREND system is a Fluorescence immunoassay analyzer that uses disposable cartridge to provide quantitative results in 5 minutes. Test menus are PSA/TSH/Free T4/ Total T3/Testosterone/Cardiac Triple(CK-MB, Myoglobin, Troponin I)/BNP/PCT/Vitamin D

- Images and Attachment : Refer to the attached file

l Product 2

- Name : BioTracer^TM

- Intended Use : BioTracer is an immunochromatography based one-step in vitro diagnostic test for the qualitative determination in using human serum or plasma or whole blood. Test menus are

- Hepatitis: HBsAg, Anti-HBs, HCV

- Infectious Disease: HIV 1/2, HIV 1/2/O, Dengue Combo, Dengue NS1, Dengue IgG/IgM, Malaria P.f/PAN, Malaria P.f/P.v, Malaria Ab P.f/P.v, Malaria Ab/Typhoid Ab, Influenza A&B, H.pylori Ag H.pylori, TB, Syphilis, HSV-2

- Gastrointestinal Infection : Norovirus, Rotavirus, Adenovirus, Rota/Adeno, Noro/Rota/Adeno

- Tumor Marker : AFP, CEA, PSA, FOB

- Fertility Hormone : hCG, LH

- Cardiac Marker : Troponin I, Cardiac 3 in 1

- Images and Attachment : Refer to the attached file

l Product 3

- Name : BUDDI^TM

- Intended Use : Smart rapid diagnostic test analyzer

- BUDDI is an image analyzer that evaluates the line signal intensities on the test device. This device helps you clarify decision making of unclear test line.

- Images and Attachment : Refer to the attached file

l Product 4

- Name : ADAM-rWBC

- Intended Use : ADAM-rWBC is an analytical device for counting the number of residual white blood cells (rWBCs) in leukoreduced blood products. The device is to ensure the number of rWBCs and the standards to minimize complications associated with the transfusions performance

- Images and Attachment : Refer to the attached file