Identity
- Trade Name
- Dimension Vista® V-LTYE® Diluent 3 FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- V-LYTE® Diluent, 2x1.5 L FDA UDI
- Model / Reference
- 10445202 FDA UDI
- Description
- V-LYTE® Diluent, 2x1.5 L FDA UDI
Identifiers
- Catalog Number
- K835 FDA UDI
- Primary DI / UDI-DI
- 00842768016240 FDA UDI
- 510(k) Number
- K051087 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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 Vista® V-LTYE® Diluent 3 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Buffered sample diluent IVD.
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- ARCHITECT — Abbott Laboratories, Inc. · Class II
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- IMMULITE® 2000 Systems HCY Homocysteine Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K051087 also covers:
- Dimension Vista Barcode Labels — Siemens Healthcare Diagnostics
- Dimension Vista® 1500 Intelligent Lab System — Siemens Healthcare Diagnostics
- Dimension Vista® 500 — Siemens Healthcare Diagnostics
- Dimension Vista® 500 Intelligent Lab System — Siemens Healthcare Diagnostics
- Dimension Vista® Aliquot Plates — Siemens Healthcare Diagnostics
- Dimension Vista® Cuvette Wash Solution 5 — Siemens Healthcare Diagnostics
- Dimension Vista® Cuvettes — Siemens Healthcare Diagnostics
- Dimension Vista® Empty Vials Kit — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge BUN — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge CHK — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge EMPTY — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge PHNO — Siemens Healthcare Diagnostics
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 f96d45fc-b77c-4860-9462-f4830d83bd40 37 fields · synced May 30, 2026