Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Phosphate buffer/Sorenson buffer solution IVD FDA UDI
- Device Name
- "Phosphate Buffer pH 6.6/7.2 is used as a buffer in staining peripheral blood and bone marrow smears to aid in the diagnosis of general pathology specimens. Phosphate Buffer pH 6.6 and Phosphate Buffer pH 7.2 are white crystalline powders that, when reconstituted, yield 1 liter of clear liquid. These buffers are designed to be used with the Epredia Giemsa, Wright, Wright-Giemsa, May-Grünwald, and Jenner hematology stains" FDA UDI
- Model / Reference
- Phosphate Buffer pH 6.6 FDA UDI
- Description
- "Phosphate Buffer pH 6.6/7.2 is used as a buffer in staining peripheral blood and bone marrow smears to aid in the diagnosis of general pathology specimens. Phosphate Buffer pH 6.6 and Phosphate Buffer pH 7.2 are white crystalline powders that, when reconstituted, yield 1 liter of clear liquid. These buffers are designed to be used with the Epredia Giemsa, Wright, Wright-Giemsa, May-Grünwald, and Jenner hematology stains" FDA UDI
Identifiers
- Catalog Number
- 89032 FDA UDI
- Primary DI / UDI-DI
- 00673693090483 FDA UDI
- FDA Product Code
- LEF FDA UDI
- GMDN Term
- Phosphate buffer/Sorenson buffer solution 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: Phosphate buffer/Sorenson buffer solution 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 aa688cad-0150-48e6-8f3a-a0a6008d9414 34 fields · synced Jun 8, 2026