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3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set
EUDAMEDFDA UDIClass A (EU MDR)
Ref 4410229
Identity
- Trade Name
- 3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set EUDAMED96WELL RETAINER & BASE FAST FDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, reagent FDA UDI
- Device Name
- 96-Well/384-Well Standard Retainer and Base Set, a part of Genetic Analyzer Reagents and Consumables EUDAMED
- Model / Reference
- 4410229 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302007337 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302441022797 EUDAMED
- FDA Product Code
- PCA FDA UDI
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
- GMDN Term
- Nucleic acid hybridization detection IVD, reagent 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set by Life Technologies Holdings Pte Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0190302441022797 | 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 5dc6cf76-a8d6-464c-b1e4-d499d12bbd8f 61 fields · synced Sep 17, 2026
- FDA UDI 3ab251d7-4211-4813-ab91-cc9173d86e49 32 fields · synced May 30, 2026