Epredia
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693088244
- Version / Model
- Cyto-Stain ™
- Catalog Number
- 7511
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-09
- Public Version
- 1
- Public Version Date
- 2024-08-19
- Public Version Status
- New
- Public Device Record Key
- d3280d69-c3a6-4eaf-addf-5bc37c1fcb8c
Device Description
Cyto-Stain™ acts as a single-solution cytoplasmic stain, producing the full range of familiar colors seen in conventional Papanicolaou staining and providing complete control of staining intensity. The staining of Cyto-Stain™ is accomplished through a formulation based upon the differential affinities of its component dyes for various cellular components. Final cytoplasmic hues are influenced by both the prior action of Clarifier 1 and the subsequent 95% alcohol rinses. Cyto-Stain™ produces results comparable to Pap staining with one minor difference: cilia in bronchial washings stain blue-green with Cyto-Stain™ rather than red as seen in traditional Pap staining procedures
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 |
|---|---|---|---|---|
| HZJ | Stain, Papanicolau | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43587 | Biological stain IVD | A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693088244 | GS1 |