FDA UDI
In Commercial Distribution
🇺🇸 United States
CitoCBC Control
DI: 00850063751315
·
Model: 1310
·
CYTOCHIP INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CitoCBC Control
- Primary DI
- 00850063751315
- Version / Model
- 1310
- Company Name
- CYTOCHIP INC
- Labeler DUNS
- 081107751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-01
- Public Version
- 1
- Public Version Date
- 2025-07-09
- Public Version Status
- New
- Public Device Record Key
- abef9125-1e0c-439f-a7a7-9438c66bf4c4
Device Description
CitoCBC Control is a tri-level control material designed to monitor the performance of the CitoCBC Analyzer.
Device Characteristics
- Single Use
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55866 | Full blood count 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 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, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850063751315 | GS1 |