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DxH 500 Series Diluent
EUDAMEDFDA UDIClass A (EU MDR)
Ref B36845Model DxH 500 Series Diluent
Identity
- Trade Name
- DxH 500 Series Diluent EUDAMEDFDA UDI
- Generic Name
- Full blood count IVD, reagent FDA UDI
- Device Name
- DxH 500 Series Diluent EUDAMEDFDA UDI
- Model / Reference
- DxH 500 Series Diluent EUDAMEDB36845 EUDAMEDFDA UDI
- Description
- DxH 500 Series Diluent FDA UDI
Identifiers
- Catalog Number
- B36845 FDA UDI
- Primary DI / UDI-DI
- 15099590671853 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902HEMDILUENT6Q EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W0202010185 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Full blood count IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8200 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
DxH 500 Series Diluent 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 | 150995902HEMDILUENT6Q | 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 c334a1b6-5c88-4c4c-9bda-35e692b43758 61 fields · synced Jun 19, 2026
- FDA UDI ff3bb11e-6cd6-491e-bab7-b1a697fa2a36 35 fields · synced May 30, 2026