Epredia

The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid…

Registry build 21.09.26

The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid when molten. The paraffin can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. Paraffin is used in tissue processing during the infiltration steps. Melting points and polymer content differ between formulations. Choosing which type of paraffin may depend on the tissue density or personal preference of the histotechnician. Softer kinds of paraffin with less polymer tend to infiltrate tissue slightly quicker during processing but yield a softer block during embedding. Softer kinds of paraffin better lend themselves to thicker sections during microtomy. Harder kinds of paraffin with a higher polymer content usually take a little more time to infiltrate the tissue during processing but yield harder blocks that allow thinner sectioning during microtomy. Harder tissue specimens are better supported with a harder paraffin block.

5manufacturers in China registered for this device type
14catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Guangdong (1).

Chinese manufacturers registered for FDA product code KEO
Manufacturer City Province Registered as Device types
Diatrust Medical Co., Ltd. Nanjing Jiangsu Manufacturer 48
Citotest Labware Manufacturing Co., Ltd. Haimen Jiangsu Repacker / relabeller 46
Citotest Scientific Co., Ltd. Nanjing Jiangsu Repacker / relabeller 46
Jiangsu Huida Medical Instruments Co., Ltd. Yancheng Jiangsu Contract manufacturer 10
Dakewe(Shenzhen) Medical Equipment Co., Ltd. Shenzhen Guangdong Repacker / relabeller 9

Record

Regulatory record for Epredia
Listed by Richard-Allan Scientific LLC, United States
FDA product code KEO
Device type Formulations, Paraffin, All
Device class Class 1
Regulation 21 CFR 864.4010
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-08-07

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Epredia
Catalogue number Size Status
HistoPlast LP In distribution
Paraffin, Type 1 In distribution
Paraffin, Type 9 In distribution
Paraffin, Type 3 In distribution
Paraffin, Type 6 In distribution
Paraffin, Type L In distribution
HistoPlast IM In distribution
HistoPlast LP In distribution
HistoPlast IM In distribution
Precision Cut In distribution
Paraffin, Type H In distribution
Histoplast In distribution
HistoPlast PE paraffin kit In distribution
HistoPlast PE In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Leica Biosystems Leica Biosystems Richmond, Inc. 14
Tissue-Tek Xpress® Sakura Finetek U.S.A., Inc. 1

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer