FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693228329
·
Model: Formal-Fixx™ Concentrate
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693228329
- Version / Model
- Formal-Fixx™ Concentrate
- Catalog Number
- 6764254
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-25
- Public Version
- 1
- Public Version Date
- 2024-08-02
- Public Version Status
- New
- Public Device Record Key
- 3c23cf7a-6703-4d07-b98e-d92f1b0f73d7
Device Description
Formal-Fixx is a variation of neutral buffered formalin with a differing buffering system. This fixative is designed especially for use with the Cytoblock processing gel. The phosphate-free buffering system prevents the formation of free formic acid, and its associated artifacts, formalin pigment. The osmolality of these fixatives allows them to be used not only for light microscopy but for electron microscopic studies as well. Zinc Formal-Fixx Concentrate is the same formulation as Formal-Fixx Concentrate but includes the mineral zinc to enhance the nuclear detail of the specimen.
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 |
|---|---|---|---|---|
| LDY | Fixative, Formalin-Containing | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57758 | Neutral buffered formalin IVD | A neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693228329 | GS1 |