Epredia
Fixation is the initial and most important step of histology specimen preparation in pathology. 10% Neutral Buffered Formalin is the most used fixative in the histology laboratory, but in…
Fixation is the initial and most important step of histology specimen preparation in pathology. 10% Neutral Buffered Formalin is the most used fixative in the histology laboratory, but in certain circumstances, other fixatives may be desired according to tissue type or subsequent pretreatment or staining technique. Pen-Fix is an alcoholic formalin variation with the addition of a proprietary buffer salt.
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
Record
| Listed by | Richard-Allan Scientific LLC, United States |
|---|---|
| FDA product code | LDZ |
| Device type | Fixative, Alcohol Containing |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pen-Fix™ | In distribution | |
| Pen-Fix™ | In distribution | |
| Pen-Fix™ | In distribution | |
| Pen-Fix™ | In distribution | |
| Rapid-Fixx™ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 34 |
| Fixative, Alcohol Containing | Scientific Device Laboratory, Inc. | 7 |
| Camco | Cambridge Diagnostic Products, Inc. | 2 |
| Tissue-Tek Xpress® | Sakura Finetek U.S.A., Inc. | 2 |
| Barrx | Covidien LP | 2 |
| Thermo Scientific Protocol™ Parasitology System | Fisher Diagnostics | 2 |
| Chemical Service Labs, LLC | Protean Resources, LLC. | 2 |
| Alinity | Abbott Laboratories | 1 |
| Hobbs Medical Saccomanno Cell Transport System | Hobbs Medical, Inc. | 1 |
| PVA (Zn) Fix/10% Formalin 25 sets | Alpha-Tec Systems, Inc. | 1 |
| Tissue-Tek Xpress® x120 | Sakura Finetek U.S.A., Inc. | 1 |
| BD CytoRich™ Red Preservative | Becton, Dickinson AND Company | 1 |
Showing 12 of 14. All products under Fixative, Alcohol Containing
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.