Identity
- Trade Name
- CellaVision® Advanced RBC Application DM96 FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- When implemented together with CellaVision DM96 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics FDA UDI
- Model / Reference
- CAR-960099 FDA UDI
- Description
- When implemented together with CellaVision DM96 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics FDA UDI
Identifiers
- Catalog Number
- CAR-960099 FDA UDI
- Primary DI / UDI-DI
- 07350040973752 FDA UDI
- 510(k) Number
- K171315 FDA UDI
- FDA Product Code
- JOY FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laboratory instrument/analyser application software IVD
CellaVision® Advanced RBC Application DM96 by Cellavision AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cellavision AB
Sources (1)
- FDA UDI c8259a0f-d410-4cd4-829c-de544a536cfe 36 fields · synced May 30, 2026