Identity
- Trade Name
- 3500 Dx Genetic Analyzer EUDAMEDFDA UDI
- Generic Name
- Nucleic acid sequence analyser IVD, Sanger sequencing FDA UDI
- Device Name
- Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers EUDAMEDINSTRUMENT,3500 DX FDA UDI
- Model / Reference
- 4405182 (A27772) EUDAMED4405182 FDA UDI
- Description
- INSTRUMENT,3500 DX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302005937 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302TCF00005084L EUDAMED
- FDA Product Code
- PCA FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Nucleic acid sequence analyser IVD, Sanger sequencing FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Nucleic acid sample preparation instrument IVD
3500 Dx Genetic Analyzer by Life Technologies Holdings Pte Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0190302TCF00005084L | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED 6b2bfba3-a41c-4b05-8853-08152fff5aca 61 fields · synced Jul 20, 2026
- FDA UDI 725d397f-8a90-47f0-9d41-be2215d4bba0 33 fields · synced May 29, 2026