FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693090483
·
Model: Phosphate Buffer pH 6.6
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693090483
- Version / Model
- Phosphate Buffer pH 6.6
- Catalog Number
- 89032
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-05
- Public Version
- 1
- Public Version Date
- 2024-09-13
- Public Version Status
- New
- Public Device Record Key
- aa688cad-0150-48e6-8f3a-a0a6008d9414
Device 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"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LEF | Stains, Dye Powder | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59119 | Phosphate buffer/Sorenson buffer solution IVD | A phosphate buffer or Sorenson buffer solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693090483 | GS1 |