FDA Registration
Active
🇨🇳 China
NadPrep Methyl Stubby Adpater (UDI) Module Set B1 (with 10 nt Index),?Caler NanoBlockers (for Illumina),
Reg #: 3016245391
·
FEI: 3016245391
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NANODIGMBIO (NANJING) BIOTECHNOLOGY CO., LTD
- Registration Number
- 3016245391
- FEI Number
- 3016245391
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 3-4, Tower A01, 142 Huakang Road, Jiangbei New District
- City
- Nanjing Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Nanodigmbio (Nanjing) Biotechnology Co., Ltd
- Operator Number
- 10090403
- Address
- Floor 3-4, Tower A01, 142 Huakang Road, Jiangbei New District
- City
- Nanjing
- State
- Jiangsu
- Postal Code
- 210000
- Country
- CN
- Correspondent
- KAIDI XIE
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2024-03-24 |
Proprietary Names
NadPrep Methyl Stubby Adpater (UDI) Module Set B1 (with 10 nt Index),?Caler NanoBlockers (for Illumina),
NadPrep Universal Stubby Adapter (UDI) Module Set E1,
NEXome XP Panel v1, NanOnco Plus Panel v3, HiSNP Ultra Panel v1, NEX-t Panel v1,
OncoFu Elite (for RNA) Panel v1, NanOnCT Panel v1, HLAtyping Panel v2
NadPrep DNA Library Preparation Kit (for Illumina), NadPrep EZ DNA Library Preparation Module v2,
NadPrep Methyl Library Preparation Module, NadPrep DNA Methyl Bisulfite Conversion Module,
?Caler NanoBlockers (for MGI), ?Caler Hybrid Capture Reagents v2, NadPrep NanoBlockers (for MGI, DI),
NadPrep UMI Adapter Kit Set B1 (with 10 nt Index), NadPrep Universal Adapter (MDI) Module Set E1 (for MGI),
NadPrep NEM Fragment Module, NadPrep DNA Library Preparation Module (for MGI),
NadPrep NanoBlockers (for Illumina®), NadPrep ES Hybrid Capture Reagents,?Caler AML Panel v1, NEXome Mini Panel,
Establishment Types
Manufacture Medical Device