FDA UDI
In Commercial Distribution
🇺🇸 United States
CAST® Wash Buffer Basophil
DI: EBUHBCCRWB10
·
Model: B-CCR-WB10
·
Bühlmann Laboratories AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAST® Wash Buffer Basophil
- Primary DI
- EBUHBCCRWB10
- Version / Model
- B-CCR-WB10
- Company Name
- Bühlmann Laboratories AG
- Labeler DUNS
- 481261006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-04
- Public Version
- 1
- Public Version Date
- 2025-03-12
- Public Version Status
- New
- Public Device Record Key
- 3e22a7bf-57ff-45c6-bb5f-8ee6a9e6814b
Device Description
CAST® Wash Buffer Basophil (B-CCR-WB10) is a formalin-saline solution used to wash, fixate and reconstitute basophils in basophil activation assays, ensuring proper sample preparation for flow cytometry analysis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| IGC | Formalin-Saline | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42651 | Buffered isotonic saline reagent IVD | A buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBUHBCCRWB10 | HIBCC |
Customer Contacts
- Phone
- (844)300-9799
- [email protected]