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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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"Gram Stain Kits – Tissue & Film Bacteria can be classified into one of two families based upon structural and compositional differences in their cell walls. Gram-positive bacteria have thick cell walls with high peptidoglycan content, whereas Gram-negative bacteria have thin cell walls with low peptidoglycan content. Both Gram-positive and Gram-negative bacteria stain with the dye- lake formed by Crystal Violet Solution and Gram’s Iodine Solution. However, during rinsing with Decolorizing Solution, this dye-lake is completely removed from the thin-walled Gram- negative bacteria, allowing them to be subsequently stained with Safranin O Stain Solution. The short duration of the decolorization step enables Gram-positive bacteria to retain the crystal violet dye-lake. Care should be taken when rinsing slides with Decolorizing Solution, as extended rinses can cause the crystal violet dye-lake to be removed from Gram-positive bacteria in addition to Gram-negative bacteria. Within the Tissue Kit only, tissue elements are then counterstained yellow by Tartrazine Stain Solution."
RICHARD-ALLAN SCIENTIFIC COMPANY
Tartrazine Stain Solution
In Commercial Distribution

  • 00673693089487 ()
88012

  • Biological stain IVD
Cytocool™ II and Ice-It™ are intended for use in histology laboratories for rapid freezing of tissue specimens. Cytocool™ II and Ice-It™ have a boiling point of -26.5° C/-15.1° F, which indicates fast freezing. These products do not cause ozone depletion and significantly reduce global warming potential. These products contain tetrafluoroethane.
RICHARD-ALLAN SCIENTIFIC COMPANY
Cytocool™ II
In Commercial Distribution

  • 00673693088985 ()
8323

  • Tissue freezing/embedding medium IVD
Clear-Rite, Citrus Clearing Solvent, Xylene Substitute, Xylene, and Toluene are a group of solvents known to act as clearing reagents in the histology laboratory for tissue processing and staining. These clearing reagents are used to “clear” tissue or make it permeable to paraffin in tissue processing. In staining, Clearants are used after alcohol which dehydrates the tissue to enable the slide to be cover slipped with a resinous mounting media.
RICHARD-ALLAN SCIENTIFIC COMPANY
Citrus Clearing Solvent
In Commercial Distribution

  • 00673693088923 ()
8301

  • Xylene solution substitute IVD
Cyto-Stain™ acts as a single-solution cytoplasmic stain, producing the full range of familiar colors seen in conventional Papanicolaou staining and providing complete control of staining intensity. The staining of Cyto-Stain™ is accomplished through a formulation based upon the differential affinities of its component dyes for various cellular components. Final cytoplasmic hues are influenced by both the prior action of Clarifier 1 and the subsequent 95% alcohol rinses. Cyto-Stain™ produces results comparable to Pap staining with one minor difference: cilia in bronchial washings stain blue-green with Cyto-Stain™ rather than red as seen in traditional Pap staining procedures
RICHARD-ALLAN SCIENTIFIC COMPANY
Cyto-Stain ™
In Commercial Distribution

  • 00673693088244 ()
7511

  • Biological stain IVD
Cyto-Stain™ acts as a single-solution cytoplasmic stain, producing the full range of familiar colors seen in conventional Papanicolaou staining and providing complete control of staining intensity. The staining of Cyto-Stain™ is accomplished through a formulation based upon the differential affinities of its component dyes for various cellular components. Final cytoplasmic hues are influenced by both the prior action of Clarifier 1 and the subsequent 95% alcohol rinses. Cyto-Stain™ produces results comparable to Pap staining with one minor difference: cilia in bronchial washings stain blue-green with Cyto-Stain™ rather than red as seen in traditional Pap staining procedures
RICHARD-ALLAN SCIENTIFIC COMPANY
Cyto-Stain ™
In Commercial Distribution

  • 00673693088213 ()
7501R

  • Biological stain IVD
Clarifier™ 2 is an aqueous glacial acetic acid rinse designed to eliminate background staining sometimes caused by excessive adhesives in the water bath such as gelatin. Clarifier™ 2 selectively removes hematoxylin staining from excess adhesive without affecting nuclear staining. This product is only effective with progressive staining an should not be used with regressive stains. Clarifier 2 was designed to be used in histology only. Clarifier™ 2 is designed for use after staining with progressive hematoxylins. After tissues have been sufficiently stained with a progressive hematoxylin, slides are removed from the stain and excess hematoxylin is removed by rinsing the sections in water. The sections are then placed into Clarifier™ 2 for 20 seconds to 40 seconds. A 1-minute water rinse should follow as this stops the reaction and rinses excess acid from the tissue section.
RICHARD-ALLAN SCIENTIFIC COMPANY
Clarifier™ 2
In Commercial Distribution

  • 00673693088176 ()
7442

  • Acid-alcohol solution IVD
Clarifier™ 1 is a reagent designed to eliminate background staining sometimes caused by excessive adhesives in the water bath such as gelatin. Clarifier™ 1 selectively removes hematoxylin staining from excess adhesive without affecting nuclear staining. This product is only effective with progressive staining and should not be used with regressive stains. Clarifier™ 1 is designed for use after staining with progressive hematoxylins. After tissues have been sufficiently stained with a progressive hematoxylin, slides are removed from the stain and excess hematoxylin is removed by rinsing the sections in water. The sections are then placed into Clarifier™ 1 for 30 seconds to 1 minute. A 1-minute water rinse should follow as this stops the reaction and rinses excess acid from the tissue section. If Clarifier™ 1 is not successful in removing the background staining, use Clarifier™ 2 in its place with a possible time reduction.
RICHARD-ALLAN SCIENTIFIC COMPANY
Clarifier™ 1
In Commercial Distribution

  • 00673693088152 ()
7441

  • Differentiation solution IVD
Differentiating Solution is intended to be used as an aid in hematoxylin staining for the diagnosis of general pathology specimens. Differentiating Solution is an acid alcohol solution to be used with the Modified Harris Hematoxylin. It is formulated as a standard 1% hydrochloric acid in 70% alcohol solution and will provide consistent differentiation results. Differentiating Solution’s mode of action is that it aggressively reacts with the tissue dye-lake complex in nuclear chromatin, resulting in the removal of the stain. Due to weak bonding in the cytoplasm, hematoxylin in this area is also easily and completely removed. Generally, two to four quick dips will be adequate for differentiation when using Differentiating Solution, followed by a 1-minute water rinse to stop the reaction and fully remove the acid from the tissue.
RICHARD-ALLAN SCIENTIFIC COMPANY
Differentiating Solution
In Commercial Distribution

  • 00673693088145 ()
74211

  • Acid-alcohol solution IVD
Differentiating Solution is intended to be used as an aid in hematoxylin staining for the diagnosis of general pathology specimens. Differentiating Solution is an acid alcohol solution to be used with the Modified Harris Hematoxylin. It is formulated as a standard 1% hydrochloric acid in 70% alcohol solution and will provide consistent differentiation results. Differentiating Solution’s mode of action is that it aggressively reacts with the tissue dye-lake complex in nuclear chromatin, resulting in the removal of the stain. Due to weak bonding in the cytoplasm, hematoxylin in this area is also easily and completely removed. Generally, two to four quick dips will be adequate for differentiation when using Differentiating Solution, followed by a 1-minute water rinse to stop the reaction and fully remove the acid from the tissue.
RICHARD-ALLAN SCIENTIFIC COMPANY
Differentiating Solution
In Commercial Distribution

  • 00673693088138 ()
74204

  • Acid-alcohol solution IVD
Clarifier™ 2 is an aqueous glacial acetic acid rinse designed to eliminate background staining sometimes caused by excessive adhesives in the water bath such as gelatin. Clarifier™ 2 selectively removes hematoxylin staining from excess adhesive without affecting nuclear staining. This product is only effective with progressive staining an should not be used with regressive stains. Clarifier 2 was designed to be used in histology only. Clarifier™ 2 is designed for use after staining with progressive hematoxylins. After tissues have been sufficiently stained with a progressive hematoxylin, slides are removed from the stain and excess hematoxylin is removed by rinsing the sections in water. The sections are then placed into Clarifier™ 2 for 20 seconds to 40 seconds. A 1-minute water rinse should follow as this stops the reaction and rinses excess acid from the tissue section.
RICHARD-ALLAN SCIENTIFIC COMPANY
Clarifier™ 2
In Commercial Distribution

  • 00673693088121 ()
7402

  • Acid-alcohol solution IVD
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