Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693106917
- Version / Model
- Resolve® Immersion Oil Low Viscosity
- Catalog Number
- M5000
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-29
- Public Version
- 1
- Public Version Date
- 2024-08-06
- Public Version Status
- New
- Public Device Record Key
- 990fbcd6-7c0d-4277-9d42-8aed0e3ffa91
Device Description
Resolve™ Immersion Oil is a clear, colorless oil that allows light transmission throughout most of the UV-VIS spectrum. Resolve Immersion Oil is manufactured using a proprietary process that removes most interfering substances, allowing for superb visualization of microscopic samples under high (oil immersion) magnification. Resolve is available in both low viscosity and high viscosity, is non-drying and non-hardening, and has a refractive index of 1.515. It contains no PCBs, eliminating toxicity and disposal problems. Consult your microscope instruction manual for compatibility. Trak 300™ oil is intended for use with the HEMATRAK® automated differential system. The oil does not contain PCBs and is safe to use with valuable optics. The refractive index is 1.515.
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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62690 | Molecular grade procedure oil IVD | An inert oil (e.g., silicone oil, mineral oil, immersion oil) intended to be used as a barrier/seal/partitioning agent to minimize or prevent sample carryover and/or evaporation in an in vitro diagnostic assay performed on a clinical specimen (e.g., using a microwell plate), and/or to occupy the space between a microscope slide and a microscope objective lens to remove air and enhance image resolution of the microscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693106917 | GS1 |