Boule Cal
Basic Information
- Brand Name
- Boule Cal
- Primary DI
- 00812137010223
- Version / Model
- 1 x 3.0mL
- Catalog Number
- 501-606
- Company Name
- CLINICAL DIAGNOSTIC SOLUTIONS, INC.
- Labeler DUNS
- 048144997
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d2aeb6be-758b-4c9a-88c7-b91f70d2518f
Device Description
Boule Cal Hematology Calibrator is manufactured for calibration multi-parameter hematology analyzers.Multi-parameter hematology analyzers require regular calibration in order to produce accurate results on patient samples. Calibration can be accomplished by transferring information to the analyzer through fresh blood samples, which have been assayed by reference methods. A more direct and convenient approach is to use a calibrator material with System Specific Values (SSV) assigned. Boule Cal is such a material. Boule Cal is a stable suspension of red blood cells, white blood cells and platelets. Assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). A user analyzes Boule Cal on their instrument and computes calibration factors by comparing recovered values and assigned values. These factors provide the basis for making adjustments to the instrument.
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 | 00812137010223 | GS1 |
Customer Contacts
- Phone
- 8004533328
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius