CueSee® CO-OX
Basic Information
- Brand Name
- CueSee® CO-OX
- Primary DI
- 08718734961086
- Version / Model
- LVA
- Catalog Number
- AN01486A04
- Company Name
- Eurotrol B.V.
- Labeler DUNS
- 412925992
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-19
- Public Version
- 1
- Public Version Date
- 2021-12-27
- Public Version Status
- New
- Public Device Record Key
- a3cd069a-4ea2-4e7c-b680-f40dc4b06885
Device Description
CueSee® CO-OX LVA is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory). CueSee® CO-OX LVA contains: 1 bottle of CueSee® CO-OX S1A (DI: 08718734961000), 1 bottle of CueSee® CO-OX S2A (DI: 08718734961017), 1 bottle of CueSee® CO-OX S3A (DI: 08718734961024), 1 bottle of CueSee® CO-OX S4A (DI: 08718734961031) and 1 bottle of CueSee® CO-OX S5A (DI: 08718734961048).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GGM | Control, Hemoglobin | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55878 | Multiple haemoglobin subtype IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple subtypes of haemoglobin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08718734961086 | GS1 |