FDA UDI
In Commercial Distribution
🇺🇸 United States
XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA )
DI: 05055273218732
·
Model: XN10502
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA )
- Primary DI
- 05055273218732
- Version / Model
- XN10502
- Catalog Number
- XN10502
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-21
- Public Version
- 1
- Public Version Date
- 2023-12-29
- Public Version Status
- New
- Public Device Record Key
- 0eb594cc-a61b-45ca-9414-4ca7ffcd0b7f
Device Description
The Xanthochromia Negative 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 Negative Control is unassayed without target values and is suitable for use on various UV spectrophotometer analysers. Xanthochromia Negative 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47869 | Multiple-type clinical chemistry analyte profile IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273218732 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius