Identity
- Trade Name
- Iris FDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- iQ Body Fluids Conical Tubes EUDAMEDThe tubes are specimen receptacles for body fluids. The plastic test tubes are 12 mL and contain 500 per package. FDA UDI
- Model / Reference
- 800-3215 EUDAMEDFDA UDI
- Description
- The tubes are specimen receptacles for body fluids. The plastic test tubes are 12 mL and contain 500 per package. FDA UDI
Identifiers
- Catalog Number
- 800-3215 FDA UDI
- Primary DI / UDI-DI
- 10837461002321 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902DXUACCESSORYDM EUDAMED
- Unit of Use DI
- 00837461002324 EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W050301020180 SAMPLES ANALYSES, PLASTIC TUBES - ACCESSORIES EUDAMED
- GMDN Term
- Assay container IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iQ Body Fluids Conical Tubes by Beckman Coulter Ireland 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 | 150995902DXUACCESSORYDM | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (2)
- EUDAMED 82c72c11-13f1-4b97-8157-b4c6935bed05 61 fields · synced Jul 8, 2026
- FDA UDI d0bbff0d-9fb8-4a8c-ba17-f2fc847428b3 35 fields · synced May 30, 2026