Cytovale Imaging Analysis Module
- Primary DI
- 00860005204601
- Brand
- Cytovale Imaging Analysis Module
- Company
- Cytovale Inc
- Model
- CV-IAM-001
- Catalog number
- CV-IAM-001
- Device description
- The Imaging Analysis Module (IAM) of the Cytovale System. Used to analyze images of the leukocytes under test.
- Published
- 2025-07-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QUT | Deformability Cytometry For Sepsis Risk Assessment |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QUT | Deformability Cytometry For Sepsis Risk Assessment | Microbiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860005204601 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00860005204601 | 00860005204601 | 860005204601 | 0860005204601 |
GMDN Terms
| Term | Definition |
|---|
| Leukocyte deformability IVD, kit, rapid microfluidic cytometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of the deformability of leukocytes in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid microfluidic cytometry method. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the early diagnosis of sepsis. It is not intended to be used for self-testing. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 831 millibar | 1013 millibar | |
| Handling Environment Humidity | 20 Percent (%) Relative Humidity | 80 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 18 Degrees Celsius | 28 Degrees Celsius | |
| Storage Environment Atmospheric Pressure | 831 millibar | 1013 millibar | |
| Storage Environment Humidity | 20 Percent (%) Relative Humidity | 80 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 18 Degrees Celsius | 28 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 078418950
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00860001900507 | Cytovale Reagent Kit | CV-REA-101 | CV-REA-101 | 2025-07-03 |
| 00860005204656 | Cytovale Diluent | CV-DIL-001 | CV-DIL-001 | 2025-07-03 |
| 00860005204663 | Cytovale Cleanse | CV-CLS-001 | CV-CLS-001 | 2025-07-03 |
| 00860001900538 | IntelliSep Quality Control Kit | CV-ICL-001 | CV-ICL-001 | 2025-07-03 |
| 00860001900583 | Cytovale Sample Preparation Module | CV-SPM-001 | CV-SPM-001 | 2025-07-03 |
| 00860001900590 | Cytovale Cell Imaging Module | CV-CIM-001 | CV-CIM-001 | 2025-07-03 |
| 00860005204618 | Cytovale Reagent Kit | CV-REA-001 | CV-REA-001 | 2025-07-03 |
| 00860005204625 | IntelliSep Cartridge | CV-ICG-001 | CV-ICG-001 | 2025-07-03 |
Other Devices Sharing Product Codes
cytovale.com