Identity
- Trade Name
- Dimension Vista® LOCI® Reaction Vessels FDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- LOCI® Reaction Vessel, 1000 Pieces FDA UDI
- Model / Reference
- 10445212 FDA UDI
- Description
- LOCI® Reaction Vessel, 1000 Pieces FDA UDI
Identifiers
- Catalog Number
- KS855 FDA UDI
- Primary DI / UDI-DI
- 00842768016288 FDA UDI
- 510(k) Number
- K051087 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Assay container IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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: Assay container IVD, single-use
Dimension Vista® LOCI® Reaction Vessels by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 0a56bcac-d4dc-4705-b80d-57f1a6bc05f0 37 fields · synced May 30, 2026