FDA Registration
Active
🇰🇷 South Korea
SG BioScience, INC
Reg #: 3012422258
·
FEI: 3012422258
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SG BioScience, INC
- Registration Number
- 3012422258
- FEI Number
- 3012422258
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6-7F, 288, Dapsimni-ro,
- City
- Dongdaemun-gu Seoul
- Country
- KR
Owner / Operator
- Firm Name
- SG BioScience, Inc
- Operator Number
- 10076886
- Address
- 6-7F, 288, Dapsimni-ro
- City
- Dongdaemun-gu
- State
- Seoul
- Postal Code
- 02637
- Country
- KR
- Correspondent
- Semoon Oh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2026-05-27 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2020-08-04 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2024-01-10 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-08-04 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2024-11-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-05-31 |
Proprietary Names
AllrangeKit Urine Sample Collection Kit
AllrangeKit Oral Swab Collection kit
ALLTM Set, GeneTM Set (Transport medium), SELTM Set (Transport medium)
AllrangeKit Nasal Swab Collection kit
STI-12 Sample Collection and Transport Kit
AllrangeKit Urine Sample Collection kit
ALLTM Set, GeneTM Set (Brush), SELTM Set (Brush), SG Brush II
AllrangeKit Stool Sample Collection kit
AllrangeKit Saliva Sample Collection kit
InstaView COVID-19/Flu Ag Combo Control Swab
Establishment Types
Manufacture Medical Device