FDA Registration
Active
🇰🇷 South Korea
RADI BX-96/192 STD DNA Purification kit
Reg #: 3016578360
·
FEI: 3016578360
·
Expires 2025
Products
1
Proprietary Names
75
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KH MEDICAL CO., LTD.
- Registration Number
- 3016578360
- FEI Number
- 3016578360
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 201, Jinwiseo-ro, Jinwi-myeon
- City
- Pyeongtaek-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- KH Medical Co., Ltd.
- Operator Number
- 10080536
- Address
- 201, Jinwiseo-ro, Jinwi-myeon
- City
- Pyeongtaek-si
- State
- Gyeonggi
- Postal Code
- 17712
- Country
- KR
- Correspondent
- Miyoung Yang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2021-02-16 |
Proprietary Names
RADI BX-96/192 STD DNA Purification kit
RADI 192 Tissue DNA Extraction Kit
RADI BX-96/192 Viral DNA/RNA Purification Kit
RADI MX-16/32 Universal DNA-RNA Extraction kit
RADI MX-8L Cell-free DNA HQ purification kit for 6 ml
RADI MX-16/32 Blood M1 DNA purification kit
RADI MX-8L Cell-free DNA purification kit for 6 ml
RADI BX-48 Blood DNA Purification kit
RADI 32/48 Universal DNA-RNA Extraction kit
RADI MX-16/32 HBV DNA purification kit
RADI PREP Plus 48 Swab and Stool DNA/RNA Kit
RADI MX-16/32 Blood DNA/RNA purification kit
RADI MX-16/32 TB/NTM DNA purification kit
RADI BX-96/192 Urine DNA Purification Kit
RADI BX-48
RADI MX-16/32 Tissue DNA/RNA purification kit
RADI MX-16/32 Cell-free DNA Extraction kit
RADI CONCENT 32/ONE Viral DNA/RNA Purification Kit
RADI MX-8L
RADI BX-32 Blood DNA Purification kit
RADI BX-32 STD DNA Purification kit
RADI BX-192
RADI BX-32 Viral DNA/RNA Purification kit
RADI MX-16/32 Cell-free DNA HQ purification kit for 500 ul
RADI CONCENT 32/ONE Blood/Cell DNA Purification Kit
RADI 48 Viral DNA/RNA Extraction kit
RADI MX-16/32 Cell-free DNA/RNA purification kit
RADI MX-16/32 STD DNA/RNApurification kit
RADI CONCENT 96 +
RADI 192 Whole Blood DNA/RNA Extraction Kit
RADI MX-16/32 Saliva DNA purification kit
RADI MX-16/32 Tissue DNA purification kit
RADI 192 Viral DNA/RNA Extraction kit
RADI MX-16/32 HPV DNA purification kit
RADI Prep Plus 48 Swab DNA/RNA Extraction kit
RADI MX-16/32 TB/NTM DNA/RNA purification kit
RADI MX-16/32 STD DNA purification kit
RADI PREP Swab and Stool DNA/RNA Kit
RADI 32 Viral DNA/RNA Extraction kit
RADI BX-96 Blood DNA Purification kit
RADI 48 Tissue DNA Extraction Kit
RADI PREP Plus Swab and Stool DNA/RNA Kit
RADI MX-8L Blood midi DNA purification kit
RADI BX-96
RADI BX-48 Viral DNA/RNA Purification kit
RADI MX-16/32 Cell-free DNA HQ purification kit for 1 ml
RADI MX-16/32 Cell DNA/RNA purification kit
RADI 192 Bacteria DNA Extraction Kit
RADI 96/192 Universal DNA-RNA Extraction Kit
RADI MX-16/32 Urine DNA Purification Kit
RADI MX-8L Cell-free DNA HQ purification kit for 2 ml
RADI MX-32
RADI MX-16/32 Viral DNA/RNA Purification Kit
RADI MX-16/32 Cell-free DNA purification kit
RADI CONCENT 32
RADI 48 Bacteria DNA Extraction Kit
RADI MX-16/32 RV DNA purification kit
RADI BX-48 STD DNA Purification kit
RADI PREP PLUS Universal DNA/RNA KIT
RADI MX-16
RADI MX-8L Cell-free DNA purification kit for 2 ml
RADI 48 Whole Blood DNA/RNA Extraction Kit
RADI CONCENT +
RADI CONCENT 48
RADI PREP Plus 48
RADI MX-16/32 FFPE DNA purification kit
RADI MX-16/32 Blood DNA purification kit
RADIONE Universal DNA/RNA Extraction kit
RADI MX-16/32 Saliva DNA/RNA purification kit
RADI EXTRACTOR 32
RADI BX-32
RADI PREP Plus
RADI MX-16/32 Cell DNA purification kit
RADI EXTRACTOR 192
RADI BX-32 Urine DNA Purification Kit
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device