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Sirius 2 Tube Luminometer
EUDAMEDFDA UDIClass A (EU MDR)
Ref 8401801Model 84018-01
Identity
- Trade Name
- Sirius 2 Tube Luminometer EUDAMEDFDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- Sirius 2 Tube Luminometer EUDAMEDThe Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence. FDA UDI
- Model / Reference
- 84018-01 EUDAMEDFDA UDI8401801 EUDAMED
- Description
- The Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence. FDA UDI
Identifiers
- Catalog Number
- 8401801 FDA UDI
- Primary DI / UDI-DI
- B17384018010 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B1738401801NE EUDAMED
- Direct Marketing DI
- B17384018010 EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W02039099 VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sirius 2 Tube Luminometer by Spectral Medical Inc. — 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 | ++B1738401801NE | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Spectral Medical Inc.
- EUDAMED SRN
- CA-MF-000007450
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 89b8478c-f08f-42c1-827c-fc367bafa615 61 fields · synced Jul 15, 2026
- FDA UDI 99aab42b-0177-4a79-a321-69bb9f2c13c9 36 fields · synced May 30, 2026