Identity
- Trade Name
- Direct Bilirubin EUDAMEDAU FDA UDI
- Generic Name
- Conjugated (direct) bilirubin IVD, kit, spectrophotometry FDA UDI
- Device Name
- Direct Bilirubin EUDAMEDFDA UDI
- Model / Reference
- OSR6211 EUDAMEDFDA UDI
- Description
- Direct Bilirubin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590020033 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995901OSR6211LV EUDAMED
- 510(k) Number
- K924963 FDA UDI
- FDA Product Code
- CIG FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Conjugated (direct) bilirubin IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1110 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
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
Yes
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
Yes
FDA UDI
Category: Nucleic acid extraction/isolation kit IVD
Direct Bilirubin by Beckman Coulter, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 150995901OSR6211LV | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (2)
- EUDAMED 9141d7b8-b334-4815-a39a-bf240573c526 61 fields · synced Jul 18, 2026
- FDA UDI 051ee829-c582-4602-9b57-f998b8e5e5fe 34 fields · synced May 30, 2026