FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693088251
·
Model: OG-6 Papanicolaou Stain
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693088251
- Version / Model
- OG-6 Papanicolaou Stain
- Catalog Number
- 75204
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- Not 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
- 4915e9f7-3d91-42f0-8195-55aa86162fb7
- Distribution End Date
- 2024-08-09
Device Description
OG-6 and Modified OG are ready-to-use cytoplasmic counterstains that stain keratinized cells orange. A well-preserved or fixed slide with adequate exposure to 95% alcohol or a commercial spray fixative is highly recommended for optimal staining results.OG-6 has a specific affinity for keratinized cells and will not stain other cellular constituents. When used in conjunction with EA stains, the end user can expect traditional staining results that are consistent and familiar. Stain filtering is recommended to remove cells shed off of slides in the cytology staining process.
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 | 00673693088251 | GS1 |