FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693089098
·
Model: Tissue Section Adhesive 500 mL Ea
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693089098
- Version / Model
- Tissue Section Adhesive 500 mL Ea
- Catalog Number
- 86014
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-30
- Public Version
- 1
- Public Version Date
- 2024-08-07
- Public Version Status
- New
- Public Device Record Key
- 888209c5-db8b-4de8-82f2-31528f900333
Device Description
Tissue Section Adhesive is for use in the water bath to increase the affinity of the tissue for the slide. Pre-mixed and ready-to-use, this adhesive will not interfere with staining reactions and does not create background residue. It also improves adhesion for techniques utilizing heat. Do not use this product with pre-coated slides.
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 |
|---|---|---|---|---|
| 64432 | Microscope slide adhesion agent IVD | A substance (e.g., solution) intended to enhance adhesion of a clinical tissue section specimen to a microscope slide, during pathology specimen preparation. It is typically diluted in water (e.g., water bath) for submersion of the slide prior to tissue specimen placement. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693089098 | GS1 |