Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- "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." FDA UDI
- Model / Reference
- Sodium Metabisulfite (1%) FDA UDI
- Description
- "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." FDA UDI
Identifiers
- Catalog Number
- 88042 FDA UDI
- Primary DI / UDI-DI
- 00673693202015 FDA UDI
- FDA Product Code
- LED FDA UDI
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biological stain IVD
Epredia by Richard-Allan Scientific LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard-Allan Scientific LLC
Sources (1)
- FDA UDI 854aa197-129e-4bfe-abb6-a39667f5c274 34 fields · synced Jun 8, 2026