Identity
- Trade Name
- Diatro•Dil-DIFF FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Diatro•Dil-DIFF diluent is a buffered, stabilized and microfiltered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of erythrocytes (RBC), leukocytes (WBC) and the leukocyte subpopulations, thrombocytes (PLT) and measurement of hemoglobin (HGB) concentration on Diatron hematology analyzers. FDA UDI
- Model / Reference
- D101 FDA UDI
- Description
- Diatro•Dil-DIFF diluent is a buffered, stabilized and microfiltered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of erythrocytes (RBC), leukocytes (WBC) and the leukocyte subpopulations, thrombocytes (PLT) and measurement of hemoglobin (HGB) concentration on Diatron hematology analyzers. FDA UDI
Identifiers
- Catalog Number
- D1012 FDA UDI
- Primary DI / UDI-DI
- 05999883586082 FDA UDI
- FDA Product Code
- GIF FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 20 Liter FDA UDI
Category: Buffered sample diluent IVD
Diatro•Dil-DIFF by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag — Class I — FDA UDI…
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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
Sources (1)
- FDA UDI 33b12cb2-0301-4331-b7a9-c405468d4001 37 fields · synced May 30, 2026