Identity
- Trade Name
- NATCH S-F11C System FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- The NATCH S-F11C System is intended for extracting and purifying nucleic acids from human samples. Instrument should be used by trained operators in clinical laboratories processing samples for molecular testing FDA UDI
- Model / Reference
- S-F11C (US) FDA UDI
- Description
- The NATCH S-F11C System is intended for extracting and purifying nucleic acids from human samples. Instrument should be used by trained operators in clinical laboratories processing samples for molecular testing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06955792714694 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nucleic acid sample preparation instrument IVD
NATCH S-F11C System by Sansure Biotech Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
Sources (1)
- FDA UDI ec86f17e-1ff5-40fa-8477-da201a579cfc 35 fields · synced May 30, 2026