Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Modified Steiner-Steiner Silver Stain Kit aids in identifying spirochetes and non-filamentous bacteria in tissue sections for the diagnosis of general pathology specimens. Microorganisms that stain positively with this technique have a cell wall that will adsorb silver from a silver solution (argyrophilic). The silver is first adsorbed in a non-visible form and is subsequently reduced by the Working Reducing Solution (hydroquinone) to a visible metallic silver. FDA UDI
- Model / Reference
- Silver Nitrate Solution #2 FDA UDI
- Description
- Modified Steiner-Steiner Silver Stain Kit aids in identifying spirochetes and non-filamentous bacteria in tissue sections for the diagnosis of general pathology specimens. Microorganisms that stain positively with this technique have a cell wall that will adsorb silver from a silver solution (argyrophilic). The silver is first adsorbed in a non-visible form and is subsequently reduced by the Working Reducing Solution (hydroquinone) to a visible metallic silver. FDA UDI
Identifiers
- Catalog Number
- 88021 FDA UDI
- Primary DI / UDI-DI
- 00673693089661 FDA UDI
- FDA Product Code
- LEE 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 70907a0d-cee7-487d-8ffc-d59b5f749b4d 34 fields · synced Jun 8, 2026