FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693088008
·
Model: Gill 1 Hematoxylin (Series R)
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693088008
- Version / Model
- Gill 1 Hematoxylin (Series R)
- Catalog Number
- 72511
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-03
- Public Version
- 1
- Public Version Date
- 2024-09-11
- Public Version Status
- New
- Public Device Record Key
- e96f9604-3ebd-4961-ae38-3388681c7149
Device Description
Gill Hematoxylin 1, 2, and 3 are rapid, progressive hematoxylins that are widely known and respected in the histology and cytology fields. They offer convenience and choice of stain intensity. Gill hematoxylins are ready to use and will provide familiar, consistent, well-delineated results. Stain filtering may be needed to remove sheen caused by oxidation or cells shed off of slides in the cytology staining process. Gill 1 is the least intense stain and is most commonly used in cytology and in special stains. Gill 2 is a moderately intense stain and is most commonly used in histology, with some limited use in cytology. Gill 3 is an intense stain and is exclusively used in histology as well as staining of plastic sections.
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 |
|---|---|---|---|---|
| HYJ | Hematoxylin | 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 | 00673693088008 | GS1 |