Identity
- Trade Name
- Dimension® Sample Diluent FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Sample Diluent, 2 bottles, 50 mL per bottle FDA UDI
- Model / Reference
- 10444875 FDA UDI
- Description
- Sample Diluent, 2 bottles, 50 mL per bottle FDA UDI
Identifiers
- Catalog Number
- 791092901 FDA UDI
- Primary DI / UDI-DI
- 00842768000119 FDA UDI
- FDA Product Code
- JMG FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5340 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Buffered sample diluent IVD
Dimension® Sample Diluent by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- IMMULITE® 2000 Systems HCY Homocysteine Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 0d1fefbc-cfb2-4076-b8ec-ad2ca82da2d1 36 fields · synced Jun 8, 2026