Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693235747
- Version / Model
- Rapid Chrome™ Papanicolaou Staining Kit
- Catalog Number
- 9990020
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-04
- Public Version
- 1
- Public Version Date
- 2024-09-12
- Public Version Status
- New
- Public Device Record Key
- 1605b4ad-0990-4372-be83-a3896ef925de
Device Description
The Rapid-Chrome™ Papanicolaou Staining Kit is specially designed to facilitate the staining of cytology specimens. It is ideally suited to quickly stain fine needle aspirates, and it also prevents cross-contamination of routine staining dishes from high-risk cases. With the Rapid-ChromeTM Papanicolaou Staining Kit, all of the reagents needed for Pap-stained cytology specimens are supplied in one convenient, portable tray. Reagents are sequentially aligned so that the user can dip slides progressively from jar to jar. Additionally, die-cut slots in the tray base accommodate jar lids in order to reduce potential cross-contamination of reagents as well as required counter space. All reagents are sequentially aligned to allow the slide to be moved from one jar to the next.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 | 00673693235747 | GS1 |