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Xanthochromia Positive Control (xanthochromia Control +)
EUDAMEDFDA UDIClass B (EU MDR)
Ref XN10505
Identity
- Trade Name
- XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +) EUDAMEDXANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA ) FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- XANTHOCHROMIA CONTROL EUDAMEDThe Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bilirubin and Oxyhaemoglobin for monitoring of Subarachnoid-haemorrhage testing in Cerebrospinal Fluid (CSF) for Xanthochromia using a spectrophotometer. Xanthochromia Positive Control is unassayed, without target values and is suitable for use on various UV spectrophotometer analysers. Xanthochromia Positive Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI
- Model / Reference
- XN10505 EUDAMEDFDA UDI
- Description
- The Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bilirubin and Oxyhaemoglobin for monitoring of Subarachnoid-haemorrhage testing in Cerebrospinal Fluid (CSF) for Xanthochromia using a spectrophotometer. Xanthochromia Positive Control is unassayed, without target values and is suitable for use on various UV spectrophotometer analysers. Xanthochromia Positive Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273218725 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BXTHPON1553F EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W0101050102 UNASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Northern 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Xanthochromia Positive Control (xanthochromia Control +) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 50552732BXTHPON1553F | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 1b27b44e-2802-45b6-b4dd-c389bec59827 61 fields · synced Jul 11, 2026
- FDA UDI 93663247-6b61-41b1-b165-b4be1cdbc7ea 35 fields · synced May 29, 2026