Epredia 88026

GUDID 00673693089760

"Modified Grocott’s Methenamine Silver Stain Kit (Chromic Acid) is intended for use as an aid to identify fungal organisms and basement membranes in tissue sections for the diagnosis of general pathology specimens. Fungal cell walls are rich in polysaccharides known as glucans. Treatment with either periodic acid or chromic acid oxidizes these polysaccharides to form aldehyde groups; however, chromic acid is the stronger oxidizer. Chromic acid will achieve a greater degree of oxidation, rendering some chemical groups non-reactive with silver so that they are not demonstrated within the final stain. This greater level of oxidation also results in reduced background staining of basement membranes and collagen fibers, as well as more effective demonstration of Pneumocystis jiroveci (formerly classified as Pneumocystis carinii) and Histoplasma capsulatum (the causative organism of Histoplasmosis). After oxidation, Sodium Metabisulfite Solution removes residual Chromic Acid Solution from the tissue. The aldehyde groups react with the silver ions present in the Working Methenamine Silver Solution and reduce them to form visible metallic silver. Gold Chloride Solution tones the sections and intensifies the reduced silver by forming a silver-gold complex. Sodium Thiosulfate Solution removes any unreduced silver from the tissue sections, followed by Fast Green Stain Solution which produces a light green background to further enhance contrast."

RICHARD-ALLAN SCIENTIFIC COMPANY

Biological stain IVD

• Primary Device ID: 00673693089760
• NIH Device Record Key: 9e82e8ca-7987-4d48-8dc1-57eba67f34ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epredia
• Version Model Number: Gold Chloride Solution (0.1%)
• Catalog Number: 88026
• Company DUNS: 929504710
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673693089760 [Primary]

FDA Product Code

• HYH: Gold Chloride

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-16
• Device Publish Date: 2024-09-06

On-Brand Devices [Epredia]

• 00673693718967: RM-2104-R7-A
• 00673693718868: MS-314-S1-A
• 00673693718851: MS-314-S0-A
• 00673693718844: MS-314-S-A
• 00673693718837: MS-314-RQ-A
• 00673693718813: MS-1919-RQ-A
• 00673693718806: MS-1919-R7-A
• 00673693718790: MS-1919-A0-A
• 00673693718783: MS-1919-A1-A
• 00673693718776: MS-1919-A-A
• 00673693658386: MS-730-P-A
• 00673693658331: MS-298-RQ-A
• 00673693658287: MS-298-P-A
• 00673693658249: MS-1826-S1-A
• 00673693658225: MS-1826-S-A
• 00673693658201: MS-1826-R7-A
• 00673693658188: MS-1458-S1-A
• 00673693658164: MS-1458-S-A
• 00067369371882: MS-314-R7-A
• 00673693719049: RM-9130-RQ-A
• 00673693719032: RM-9130-R7-A
• 00673693719025: RM-9130-A1-A
• 00673693719018: RM-9130-A0-A
• 00673693719001: RM-9130-A-A
• 00673693718998: RM-2104-S0-A
• 00673693718981: RM-2104-S-A
• 00673693718974: RM-2104-RQ-A
• 00673693659017: RM-9103-S1-A
• 00673693658997: RM-9103-S-A
• 00673693658980: RM-9103-RQ-A
• 00673693658973: RM-9103-R7-A
• 00673693658898: RM-2112-S-A
• 00673693658812: RB-9070-RQ-A
• 00673693658805: RB-9070-R7-A
• 00673693658782: RB-9070-P1-A
• 00673693658768: RB-9070-P-A
• 00673693658751: RB-9031-RQ-A
• 00673693658720: RB-9031-P1-A
• 00673693658409: MS-730-P1-A
• 00673693658959: Progesterone Recept. [YR85] ASR
• 00673693658942: Progesterone Recept. [YR85] ASR
• 00673693658522: ER (Cocktail) [1D5+6F11] ASR
• 00673693658515: ER (Cocktail) [1D5+6F11] ASR.
• 00673693658508: ER (Cocktail) [1D5+6F11] ASR
• 00673693658492: ER (Cocktail) [1D5+6F11] ASR
• 00673693658454: Estrogen Receptor [1D5] ASR.
• 00673693079877: Neutral Buffered Formalin (NBF) is a general primary fixative for tissue specimens. A fixative i
• 00673693763233: Neutral Buffered Formalin (NBF) is a general primary fixative for tissue specimens. A fixative i
• 00673693755122: Neutral Buffered Formalin (NBF) is a general primary fixative for tissue specimens. A fixative i
• 00673693711609: Neutral Buffered Formalin (NBF) is a general primary fixative for tissue specimens. A fixative i