FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693248655
·
Model: CytoRich Red Collection Fluid
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693248655
- Version / Model
- CytoRich Red Collection Fluid
- Catalog Number
- B9990802
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-21
- Public Version
- 1
- Public Version Date
- 2024-07-29
- Public Version Status
- New
- Public Device Record Key
- 7102af1f-e41d-48d9-8508-ae8c6fcbbce3
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.
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LEA | Preservative, Cytological | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57752 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693248655 | GS1 |