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Sequencing Standard BigDye™ Terminator v1.1 Dx
EUDAMEDFDA UDIClass A (EU MDR)
Ref 4462113
Identity
- Trade Name
- Sequencing Standard BigDye™ Terminator v1.1 Dx EUDAMEDSequencing Standard v1.1, 3500 Dx Series FDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, control FDA UDI
- Device Name
- Sequencing Standard, a part of Genetic Analyzer Reagents and Consumables EUDAMEDSEQUENCING STD BDT V1.1 DX FDA UDI
- Model / Reference
- 4462113 EUDAMEDFDA UDI
- Description
- SEQUENCING STD BDT V1.1 DX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302000673 EUDAMEDFDA UDI
- Basic UDI-DI
- 01903024462113AU 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, control 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sequencing Standard BigDye™ Terminator v1.1 Dx 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 | 01903024462113AU | 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 7fd5a8d6-7170-45a5-ac11-f1cdd8b318ac 61 fields · synced Jul 11, 2026
- FDA UDI 3311d337-8d73-4a2f-8f11-cfd93757960d 33 fields · synced May 30, 2026