Identity
- Trade Name
- SmartCycler Dx System FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B FDA UDI
- Model / Reference
- SC2500N3-1 FDA UDI
- Description
- SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07332940004842 FDA UDI
- 510(k) Number
- K062948 FDA UDI
- FDA Product Code
- NJR FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
SmartCycler Dx System by Cepheid — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062948 also covers:
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
- SmartCycler Dx System — CEPHEID
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA UDI 60eef440-4aa9-4534-a06f-772d2f904e54 36 fields · synced Jun 8, 2026