FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693236379
·
Model: Kwik-Diff™ Solution 1
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693236379
- Version / Model
- Kwik-Diff™ Solution 1
- Catalog Number
- 9990705
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-23
- Public Version
- 1
- Public Version Date
- 2024-09-02
- Public Version Status
- New
- Public Device Record Key
- 847fba00-0809-4696-8a9b-12ee62038714
Device Description
"This staining kit simplifies quick differential staining blood smears and fine needle aspirates with its compact size making it specially ideal for FNA carts. With the Rapid-Chrome Kwik- Diff Staining Kit, all of the necessary reagents and accessories are supplied in one convenient, portable tray. Reagents are sequentially aligned so that the user can dip slides progressively from jar to jar. Additionally, die-cut slots in the tray base accommodate jar lids in order to reduce potential cross-contamination of reagents as well as required counter space. This kit can stain approximately 100 slides, although the actual number may vary based upon sample type and thickness."
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 |
|---|---|---|---|---|
| HYF | Giemsa Stain | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43587 | Biological stain IVD | A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693236379 | GS1 |