FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693483032
·
Model: Urine Cytology Collection System
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693483032
- Version / Model
- Urine Cytology Collection System
- Catalog Number
- 2940
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-22
- Public Version
- 1
- Public Version Date
- 2024-10-30
- Public Version Status
- New
- Public Device Record Key
- e10b5a3c-4516-426d-9a6b-4123a1ec082a
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 |
|---|---|---|---|---|
| LEA | Preservative, Cytological | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57743 | Cytology fixative solution IVD | An alcohol-based solution intended to be used as a fixative for a cytology specimen obtained directly from a patient, or processing of a clinical specimen, for subsequent preservation, transportation and/or in vitro diagnostic analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693483032 | GS1 |