Identity
- Trade Name
- SENSITITRE NEPHELOMETER EUDAMEDFDA UDI
- Generic Name
- Microorganism-density nephelometer IVD FDA UDI
- Device Name
- SENSITITRE NEPHELOMETER EUDAMEDThe Sensititre™ Nephelometer is used for standardizing the inoculum density of a bacterial suspension. Light from an ultrabright light emitting diode (LED) is scattered by bacteria in suspension and detected by a photodiode. The quantity of scattered light is compared with a reference value obtained by calibrating the Nephelometer with a 0.5 McFarland turbidity standard. FDA UDI
- Model / Reference
- V3011 EUDAMEDFDA UDI
- Description
- The Sensititre™ Nephelometer is used for standardizing the inoculum density of a bacterial suspension. Light from an ultrabright light emitting diode (LED) is scattered by bacteria in suspension and detected by a photodiode. The quantity of scattered light is compared with a reference value obtained by calibrating the Nephelometer with a 0.5 McFarland turbidity standard. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384474516 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384SensititreNephelSJ EUDAMED
- FDA Product Code
- JQX FDA UDI
- EMDN Code
- W02039099 VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Microorganism-density nephelometer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2700 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sensititre Nephelometer by Trek Diagnostic Systems 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 | 5032384SensititreNephelSJ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems Ltd
- EUDAMED SRN
- GB-MF-000016922
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 44789487-1f37-4795-9cbc-b29fbdc39195 61 fields · synced Jul 10, 2026
- FDA UDI 85a0100c-b354-4f9a-9ced-a1425a1eb8a2 34 fields · synced May 30, 2026