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Professional Medical Device Biocompatibility Testing Solutions

Endotoxin Detection Limulus Amebocyte Lysate (LAL) Kit (Tubular Quantitative Chromogenic Method)
TAL reagents are extracted from the blue blood of the Chinese horseshoe crab, Tachypleus tridentatus. These are often referred to alongside LAL reagents, which are derived from the North American horseshoe crab, Limulus polyphemus. Both TAL and LAL reagents perform the same function in detecting endotoxins (pyrogens).
![[FDSC] Negative Control, Rod, High-Density Polyethylene RM-E](https://material-image.wanwang.xin/1210044392979308/public/e39e7bad-60e8-4a37-8d76-caa688e2e787.png)
[FDSC] Negative Control, Rod, High-Density Polyethylene RM-E
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.

Freund's Complete Adjuvant
Freund's Complete Adjuvant (FCA)
![[FDSC] Negative Control RM-C (sheet), High-Density Polyethylene Film](https://material-image.wanwang.xin/1210044392979308/public/082d3e29-182b-4b2d-897a-8d9bd51ad376.png)
[FDSC] Negative Control RM-C (sheet), HDPF High-Density Polyethylene Film
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
![[FDSC] Positive Control RM-B (Sheet), ZDBC Polyurethane Film](https://material-image.wanwang.xin/1210044392979308/public/c56f0519-1368-46d2-be13-61f7c979807c.png)
[FDSC] Positive Control RM-B (sheet), ZDBC Polyurethane Film
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
![[FDSC] RM-H High-Density Polyethylene 2 mm × 100 mm (10 rods)](https://material-image.wanwang.xin/1210044392979308/public/e1273e87-209e-408d-a405-5122a7d261df.png)
[FDSC] RM-H High-Density Polyethylene 2 mm × 100 mm (10 rods)
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
![[For Biocompatibility Testing] Sesame Oil (Injection Grade)](https://material-image.wanwang.xin/1210044392979308/public/fe240e18-a242-47a3-8ee7-02cce210c75c.png)
Sesame Oil (Injection Grade) [For Biocompatibility Testing]
Refined Sesame Oil (Injection Grade); Material for in vitro skin sensitization testing in biological evaluation of medical devices; ISO 10993-12 Extract
![[FDSC] Biocompatibility Test: Negative RM, RM-D (Sheet) High-Density Polyethylene Sheet, Negative RM-D](https://material-image.wanwang.xin/1210044392979308/public/eb0c34c2-4ceb-4d0e-8acf-598c644b4240.png)
[FDSC] Biocompatibility Test: Negative RM, RM-D (Sheet) High-Density Polyethylene Sheet, Negative RM-D
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
![[FDSC] Positive Control Y-3, PVC granules containing 0.91% nonionic surfactant](https://material-image.wanwang.xin/1210044392979308/public/09619777-de93-4288-808b-a0c699cfd6bb.png)
[FDSC] Positive Control Y-3, PVC granules containing 0.91% nonionic surfactant
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.
![[For Biocompatibility Testing] Sesame Oil (Injection Grade)](https://material-image.wanwang.xin/1210044392979308/public/c496308a-a88c-47d0-afd0-c55d59e46da8.png)
Sesame Oil (Injection Grade) [For Biocompatibility Testing]
Refined Sesame Oil (Injection Grade); Material for in vitro skin sensitization testing in biological evaluation of medical devices; ISO 10993-12 Extract
![[FDSC] Positive Control RM-A (sheet), ZDEC polyurethane film](https://material-image.wanwang.xin/1210044392979308/public/e6fee9c2-9fcc-4968-a179-7f8cdfa39e3e.png)
[FDSC] Positive Control RM-A (sheet), ZDEC Polyurethane Film
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.

Premium Fetal Bovine Serum
Fetal Bovine Serum (FBS), FCS, Serum FBS is widely used in various cell culture applications.

High-Density Polyethylene USP Reference Standard
The High-Density Polyethylene Negative Control Plastic 1546707, manufactured under the supervision of the United States Pharmacopeial Convention (USP), is widely used in in vitro cytotoxicity testing and pharmaceutical packaging material inspection. It meets the technical parameter requirements for HDPE negative control materials as specified in the USP method YBB00012003-2015 for cytotoxicity testing.
![[FDSC] Positive Control Y-4, PVC granules, containing 5.8% nonionic surfactant](https://material-image.wanwang.xin/1210044392979308/public/3b3d2678-cbc3-4706-816f-b939faf1c99a.png)
[FDSC] Positive Control Y-4, PVC granules, containing 5.8% nonionic surfactant
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.

Free Hemoglobin (FHb) Content Detection Kit
Visible Spectrophotometry

Free Hemoglobin (FHb) Detection Kit (Orthotolidine Colorimetric Method)
For free hemoglobin in plasma samples, as well as in lysates or homogenates of cells and tissues. Based on the o-tolidine colorimetric method: ferrous heme in hemoglobin exhibits peroxidase-like activity, catalyzing the oxidation of o-tolidine to a blue-green product with an absorption peak at 63 nm; under acidic conditions, the product turns yellow with an absorption peak at 435nm,. The intensity of the yellow color is proportional to the hemoglobin concentration.
![[Sawbones]1522-11 Polyurethane Rigid Foam Blocks](https://material-image.wanwang.xin/1210044392979308/public/52b8e9a2-ddbf-4ab7-a8da-6f87270c94e2.webp)
[Sawbones]1522-11 Polyurethane Rigid Foam Block
Block, Cellular Foam, 12.5 PCF, 40 mm Thick

Free Hemoglobin (FHb) Assay Kit (Colorimetric Method)
![[Sawbones]1522-01 Polyurethane Rigid Foam Blocks](https://material-image.wanwang.xin/1210044392979308/public/658f991e-2d38-44f2-9a52-7a87ab8c3aad.webp)
[Sawbones]1522-01 Polyurethane Rigid Foam Block
Block, Solid Foam, 10 PCF, 40 mm Thick
![[Sawbones]1522-02 Polyurethane Rigid Foam Blocks](https://material-image.wanwang.xin/1210044392979308/public/a509b8d5-a2b1-4411-8361-059bb733a147.webp)
[Sawbones]1522-02 Polyurethane Rigid Foam Block
Block, Solid Foam, 15 PCF, 40 mm Thick
![[Sawbones]1522-03 Polyurethane Rigid Foam Blocks](https://material-image.wanwang.xin/1210044392979308/public/191ea2f2-ede7-4705-99d5-f37b2a90a140.webp)
[Sawbones]1522-03 Polyurethane Rigid Foam Block
Block, Solid Foam, 20 PCF, 40 mm Thick
![[Sawbones]1522-05 Polyurethane Rigid Foam Blocks](https://material-image.wanwang.xin/1210044392979308/public/0fabbd01-d922-4207-9286-e4a37fdd22d5.webp)
[Sawbones]1522-05 Polyurethane Rigid Foam Block
Block, Solid Foam, 40 PCF, 40 mm Thick

Premium Fetal Bovine Serum
This fetal bovine serum uses premium imported raw materials, undergoes strict production controls, and has extremely low endotoxin levels ((<1EU/mL)). It features a multi-stage filtration process and a 2-ton production line to ensure batch consistency.

Sodium Lauryl Sulfate
Sodium dodecyl sulfate (SDS), also known as sodium lauryl sulfate, is an anionic surfactant widely used in scientific applications, particularly in molecular biology, biochemistry, and cell biology research. Its effectiveness stems from its amphiphilic nature, which enables it to interact with both hydrophobic and hydrophilic molecules.

Masson's Trichrome Staining Kit
Masson's Trichrome Staining Kit, also known as Masson Staining Kit, is a reagent that uses a classic method to efficiently and sensitively stain cell nuclei while selectively coloring collagen fibers and muscle fibers. This kit is suitable for both paraffin-embedded and frozen tissue sections.

Hematoxylin and Eosin (H&E) Staining Solution
Hematoxylin and Eosin (H&E) staining is the most fundamental and widely used histological technique for tissue sectioning in pathology.
![[FDSC] Positive RM-F (sheet), Implantation Test (for short-term testing only), ZDEC](https://material-image.wanwang.xin/1210044392979308/public/878d5783-bbff-4003-877a-d7abdebe5c74.png)
[FDSC] Positive RM-F (sheet), Implantation Test (for short-term tests only), ZDEC
The RM series of reference plastic sheets, jointly developed by the Food and Drug Safety Center (FDSC) and the Hatano Research Institute, is a widely used standard reference material in the field of biological evaluation of medical devices. These RMs are listed in the revised draft of Japan's Basic Biological Testing Guidelines for Medical Devices (MHLW Japan) and the ISO 10993 series. The RM series consists of standardized reference materials designed to verify the reliability and sensitivity of biocompatibility testing systems. They are categorized into two main types: positive controls and negative controls.

CCK-8 Assay Kit (Cell Proliferation and Cytotoxicity Detection)
Cell Counting Kit-8 (CCK-8) enables rapid detection using the water-soluble tetrazolium salt WST-8 (chemically named: 2-(2-methoxy-4-nitrophenyl)-3-(4-nitrophenyl)-5-(2,4-disulfophenyl)-2H-tetrazole monosodium salt). In the presence of an electron-coupling reagent, WST-8 is reduced by mitochondrial dehydrogenases to produce a yellow-orange formazan dye.

XTT Cell Proliferation and Cytotoxicity Assay Kit
The XTT Cell Proliferation and Cytotoxicity Assay Kit is a colorimetric product that uses 2,3-bis[2-methoxy-4-nitro-5-sulfophenyl]-2H-tetrazolium-5-carboxanilide salt (XTT) for rapid, high-sensitivity detection of cell proliferation and cytotoxicity.

Lactate Dehydrogenase (LDH) Cytotoxicity Assay Kit
Also known as the Lactate Dehydrogenase Leakage Assay Kit or LDH Release Assay Kit. By measuring LDH activity or leakage in cell culture supernatants, it assesses drug-induced cytotoxicity.

Fixative solution (10% NBF)
Organic fixative (10% NBF), also known as neutral buffered formalin (10%), is composed primarily of formaldehyde, phosphate buffer, and deionized water. It has a pH range of 7.2–7.4 and is suitable for fixing most tissue types.

MEM (phenol red-free) medium
Minimum Essential Medium (MEM), also known as minimal essential medium, contains only 12 essential amino acids, glutamine, and 8 vitamins. Its simple composition makes it suitable for culturing a wide range of established cell lines and mammalian cell types from various sources.

Neutrophil Proliferation and Cytotoxicity Assay Kit
Cell Proliferation and Cytotoxicity Assay Kit (Neutral Red Uptake) is a kit that measures cell proliferation or cytotoxicity based on cells' ability to uptake neutral red.

Hematoxylin and Eosin (H&E) Staining Kit
Hematoxylin and Eosin (H&E) staining colors the cytoplasm red, nuclei blue-purple, and red blood cells orange-red, while other components appear in varying shades of red. It is widely used for staining tissue sections, blood smears, bone marrow sections, and cell smears in immunohistochemistry. As one of the most routine staining methods, H&E is essential in cell biology, histology, and pathology.

Masson Trichrome Stain
Classic collagen fiber stain, which distinguishes collagen fibers from muscle fibers.

DMSO (for cell freezing)
DMSO is a polar aprotic solvent used in chemical reactions, such as polymerase chain reaction (PCR), and also serves as a cryoprotectant for vitrification to preserve cells, tissues, and organs.

Isopropyl Alcohol, AR
This Isopropyl Alcohol Reagent Grade is primarily composed of 2-propanol, with the chemical formula C3H8O and CAS Registry Number 67-63-0. Produced via fractional distillation purification and subjected to rigorous quality control testing, this product meets the purity requirements for Analytical Reagent (AR) grade (≥99.5%). It is suitable for MTT colorimetric assays in in vitro cytotoxicity testing for biological evaluation of medical devices and as a background control solution for RhE skin irritation tests.

Saline (0.9% NaCl, sterile)
Physiological saline (0.9% NaCl, sterile) is a sodium chloride solution with a concentration of 0.9%. Abbreviated as SPSS (Stroke-physiological Saline Solution), it is commonly used for in vitro culture of living tissues and cells due to its osmotic pressure being equal to that of human blood plasma.

MEM Liquid Medium
Cytiva HyClone SH30024.01 MEM/EBSS Liquid Medium is a classic basal medium designed for mammalian cell culture, derived from Eagle's Minimum Essential Medium (MEM). Its optimized formulation contains all essential vitamins, minerals, and amino acids required to support cell growth and maintenance.

MTT Cell Proliferation and Cytotoxicity Assay Kit
The MTT assay is a method for detecting cell viability and growth. The MTT Cell Proliferation and Cytotoxicity Assay Kit is widely used to assess cell proliferation and cytotoxicity.

Trypsin-EDTA Solution, 0.25%, Phenol Red-Free, Filter Sterilized, for Cell Culture
Trypsin-EDTA solution is specifically designed for detaching adherent cells and dissociating tissues. It is suitable for cell passaging, primary tissue dissociation, and any biological research projects requiring single-cell suspensions.

Penicillin-Streptomycin (Double Antibiotic), 100X
This product is a penicillin-streptomycin solution specifically formulated for cell culture, prepared with high-purity penicillin and streptomycin sulfate. It is a common antibiotic additive used to prevent bacterial contamination during cell culture.
