Epredia
- Primary DI
- 00673693235877
- Brand
- Epredia
- Company
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Model
- Cytospin Collection Fluid
- Catalog number
- 9990323
- Device description
- Fixation is vital in the stabilization and maintenance of the existing form and structure of all cellular constituents. The fixative, when applied, coats, and protects cells with a water-soluble film. This film, derived from resin, coats cell preparations to preserve nuclear detail for microscopic examination and diagnosis.
- Published
- 2024-07-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| LEA | Preservative, Cytological |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LEA | Preservative, Cytological | Pathology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00673693235877 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00673693235877 | 00673693235877 | 673693235877 | 0673693235877 |
GMDN Terms
| Term | Definition |
|---|
| Saccamanno solution IVD | A solution typically containing 50% ethanol and 2% polyethylene glycol (carbowax) diluted in water, intended to be used as a fixative particularly for liquid cytologic specimens such as sputum, urine, bronchial washings, and pleural and peritoneal fluids. Saccomanno solution causes lysis of red blood cells and renders uncoagulated proteins and mucus soluble for centrifugation and filtration. |
Regulatory Flags
- DUNS number
- 929504710
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- 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 |
|---|
| 00673693181723 | Epredia | Pen-Fix™ | 6105 | 2024-11-19 |
| 00673693063494 | Epredia | Microtome Knife, 12 CM, C | 2222004 | 2024-10-29 |
| 00673693063500 | Epredia | Microtome Knife, 16 CM, C | 152020 | 2024-10-29 |
| 00673693063753 | Epredia | Microtome Knife, 30CM, C | 152050 | 2024-10-29 |
| 00673693063760 | Epredia | Microtome Knife, 12 CM, D | 152060 | 2024-10-29 |
| 00673693063777 | Epredia | Microtome Knife, 16 CM, D | 152070 | 2024-10-29 |
| 00673693063784 | Epredia | Microtome Knife, 22 CM, D | 152080 | 2024-10-29 |
| 00673693063791 | Epredia | Microtome Knife, 25 CM, D | 152090 | 2024-10-29 |
| 00673693063807 | Epredia | Microtome Knife, 30 CM, D | 152100 | 2024-10-29 |
| 00673693063814 | Epredia | Tungsten Carbide Knife, 16 CM | 152120 | 2024-10-29 |
| 00673693064200 | Epredia | Adamas Blades for Disposable Magnetic Blade Carrie | 160010 | 2024-10-29 |
| 00673693064231 | Epredia | Adamas Blades for Disposable Magnetic Blade Carrie | 160040 | 2024-10-29 |
| 00673693226707 | Epredia | Tungsten Carbide D-Profile Microtome Knives | 5601006 | 2024-10-29 |
| 00673693263177 | Epredia | Microtome Knife D-Profile 240 mm | 2222006 | 2024-10-29 |
| 00673693568074 | Epredia | HistoPlast IM | 8331K | 2024-10-29 |
| 00673693220514 | Epredia | Microtome Knife C-Profile 240 mm | 2222005 | 2024-10-28 |
| 00673693232913 | Epredia | Stainless-Steel Microtome Knives 12.5 cm | 7619 | 2024-10-28 |
| 00673693233149 | Epredia | Standard Microtome Knife 125 mm | 7702 | 2024-10-28 |
| 00673693233187 | Epredia | Standard Microtome Knife 250 mm | 7704 | 2024-10-28 |
| 00673693233200 | Epredia | Stainless-Steel Microtome Knives 18.5 cm | 7719 | 2024-10-28 |
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