Epredia

Signature Series Flex is a patented dehydrating reagent specifically designed for processing and staining of histological and cytological tissue specimens. Flex is a clear, colorless blend…

Registry build 21.09.26

Signature Series Flex is a patented dehydrating reagent specifically designed for processing and staining of histological and cytological tissue specimens. Flex is a clear, colorless blend of isopropyl and methyl alcohol. It is a non-controlled substance and does not require record keeping. Flex is available in concentrations of 80%, 95% and 100%. It is readily miscible with water to form any desired grade of alcohol. Flex is miscible with all clearing reagents. Studies have indicated that Flex does not over-dehydrate small tissue specimens as rapidly as ethyl and isopropyl alcohol, when used in accordance with the processing guidelines developed for Flex. The absence of over-dehydration during tissue processing allows for consistent results with both large and small tissue specimens. Flex can be used in tissue processing, staining and as a dye or stain solvent in place of ethyl alcohol. Flex can be used in all special stains that require dehydration in ethyl alcohol and in immunohistochemical reactions that are compatible with alcoholic dehydrants. Flex has been proven to produce brilliant hematoxylin and eosin stains, with crisp nuclear detail when used within designated guidelines. Flex is compatible with both open and closed tissue processors. Flex is a flammable product and must be stored in a flammable fire cabinet.

30manufacturers in China registered for this device type
59catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (6), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PPM
Manufacturer City Province Registered as Device types
Takara Biotechnology (Dalian) Co., Ltd. Dalian Liaoning Contract manufacturer 1
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Zhejiang Gene Science Co., Ltd. Shaoxing Zhejiang Manufacturer 31
Biomed Plastics Co. Taicang Jiangsu Contract manufacturer 29
Jinan Babio Biotechnology Co., Ltd. Jinan Shandong Manufacturer 25
AVE Science & Technology Co., Ltd. Changsha Hunan Manufacturer 22
Bioteke Corporation (Wuxi) Co., Ltd. Wuxi Jiangsu Manufacturer 21
Shenzhen Yhlo Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 19
Wuhan Landing Intelligence Medical Co., Ltd. Wuhan Hubei Manufacturer 17
Shanghai FLY Medical Devices Co., Ltd. Minhang District Shanghai Manufacturer 15
Medico Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 11

Showing 12 of 30. All 30 manufacturers in China registered for General Purpose Reagent

Record

Regulatory record for Epredia
Listed by Richard-Allan Scientific LLC, United States
FDA product code PPM
Device type General Purpose Reagent
Device class Class 1
Regulation 21 CFR 864.4010
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-07-28

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
Reagent Alcohol In distribution
Acetone High Purity In distribution
Flex 100 In distribution
Fast Flex™ Holding Solution 5 L In distribution
Isopropyl Alcohol In distribution
Flex 100 (Syntri Safeguard) In distribution
Flex 100 In distribution
100% Dehydrant In distribution
70% Isopropyl Alcohol In distribution
Acetone In distribution
Methyl Alcohol High Purity In distribution
Resolve® Immersion Oil High Viscosity In distribution
Track 300™ Automated Differential System Immersion Oil In distribution
Methyl Alcohol In distribution
Acetone High Purity In distribution
95% Dehydrant In distribution
ParaPel In distribution
Flex 95 In distribution
Denatured Ethanol High Purity In distribution
Track 300™ Automated Differential System Immersion Oil In distribution
Isopropyl Alcohol (Syntri Safeguard) In distribution
Isopropyl Alcohol In distribution
Resolve® Immersion Oil High Viscosity In distribution
Track 300™ Automated Differential System Immersion Oil In distribution
70% Dehydrant In distribution
Isopropyl Alcohol High Purity In distribution
Track 300™ Automated Differential System Immersion Oil In distribution
Denatured Ethanol High Purity In distribution
Resolve® Immersion Oil High Viscosity In distribution
70% Dehydrant In distribution
100% Dehydrant (Syntri Safeguard) In distribution
Flex 95 In distribution
Resolve® Immersion Oil High Viscosity In distribution
Isopropyl Alcohol High Purity In distribution
Methyl Alcohol High Purity In distribution
95% Dehydrant In distribution
80% Dehydrant In distribution
100% Dehydrant In distribution
Tissue Section Adhesive 500 mL Ea In distribution
Flex 80 In distribution
Flex 100 In distribution
Denatured Ethanol High Purity In distribution
Flex 80 In distribution
80% Dehydrant In distribution
95% Dehydrant In distribution
Denatured Alcohol In distribution
Resolve® Immersion Oil Low Viscosity In distribution
Flex 100 In distribution
Flex 95 In distribution
Fast Flex™ Tissue Processing System – Kit 1 3x5L In distribution
Fast Flex™ Tissue Processing System – Kit 2 3x5L In distribution
Isopropyl Alcohol High Purity In distribution
Base Mold Release In distribution
Isopropyl Alcohol In distribution
Methyl Alcohol In distribution
Reagent Alcohol In distribution
Methyl Alcohol High Purity In distribution
100% Dehydrant In distribution
Fast Flex™ Holding Solution 2.5 gal. (9.4L) In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Diagnostic BioSystems Diagnostic Biosystems 62
Alpha-Tec Systems Alpha-Tec Systems, Inc. 46
Vysis Abbott Molecular, Inc. 34
Genemed® Sakura Finetek U.S.A., Inc. 33
Edge Biologicals Inc Edge Biologicals, Inc. 25
Immunalysis Immunalysis Corporation 22
Fisherbrand Fisher Scientific Company L.L.C. 22
Bond Leica Biosystems Newcastle Ltd 16
Vitros Ortho-Clinical Diagnostics, Inc. 16
Synchron Beckman Coulter, Inc. 13
Immy Immuno-Mycologics, Inc. 12
Tissue-Tek Genie® Sakura Finetek U.S.A., Inc. 11

Showing 12 of 617. All products under General Purpose Reagent

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