CDS Hematology Calibrator
Basic Information
- Brand Name
- CDS Hematology Calibrator
- Primary DI
- 00812137010360
- Version / Model
- 1x3.0mL
- Catalog Number
- 502-040
- Company Name
- CLINICAL DIAGNOSTIC SOLUTIONS, INC.
- Labeler DUNS
- 048144997
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8bc45d50-c7a1-4da2-9bd2-e23dfacce017
Device Description
CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers. CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | Hematology | 864.8165 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55865 | Full blood count IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812137010360 | GS1 |
Customer Contacts
- Phone
- 8004533328
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius