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…
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.
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.
| 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
| 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
| 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 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
| 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.