Identity
- Trade Name
- 3500xL 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,3500XL DX FDA UDI
- Model / Reference
- 4405183 (A27856) EUDAMED4405183 FDA UDI
- Description
- INSTRUMENT,3500XL DX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302005944 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
3500xL Dx Genetic Analyzer by Life Technologies Holdings Pte Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
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 13771840-1b51-42a1-9230-cc93dda2a09d 61 fields · synced Jul 11, 2026
- FDA UDI 10b6a783-9c3a-4b23-a138-c944bcce3907 33 fields · synced May 29, 2026