Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Bluing Reagent is intended to be used as an aid in hematoxylin staining for the diagnosis of general pathology specimens. Bluing Reagent is a buffered alkaline rinse that shifts the final hue of hematoxylin from reddish-blue to traditional blue-purple. Unlike ammonia water and lithium carbonate, Bluing Reagent inhibits pH changes that can adversely affect nuclear detail and “crispness”. FDA UDI
- Model / Reference
- Bluing Reagent FDA UDI
- Description
- Bluing Reagent is intended to be used as an aid in hematoxylin staining for the diagnosis of general pathology specimens. Bluing Reagent is a buffered alkaline rinse that shifts the final hue of hematoxylin from reddish-blue to traditional blue-purple. Unlike ammonia water and lithium carbonate, Bluing Reagent inhibits pH changes that can adversely affect nuclear detail and “crispness”. FDA UDI
Identifiers
- Catalog Number
- 6769001 FDA UDI
- Primary DI / UDI-DI
- 00673693228671 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 ef3afbd1-5d93-4f29-af3b-78172f972a86 34 fields · synced Jun 8, 2026