Identity
- Trade Name
- Dimension Vista® Aliquot Plates FDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- Aliquot Plates, 30x12 (360) FDA UDI
- Model / Reference
- 10445210 FDA UDI
- Description
- Aliquot Plates, 30x12 (360) FDA UDI
Identifiers
- Catalog Number
- KS840 FDA UDI
- Primary DI / UDI-DI
- 00842768016264 FDA UDI
- 510(k) Number
- K051087 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- General specimen container IVD, no additive/medium 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: General specimen container IVD, no additive/medium
Dimension Vista® Aliquot Plates by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General specimen container IVD, no additive/medium.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- MINIGRIP COMMERCIAL — MINIGRIP COMMERCIAL LLC · Class I
- Medegen Medical Products, LLC — Medegen Medical Products · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- Tube 10ml, 100x16mm, PP — Sarstedt Aktiengesellschaft & Co.KG · Class I
- MINIGRIP COMMERCIAL — MINIGRIP COMMERCIAL LLC · Class I
- MINIGRIP COMMERCIAL — MINIGRIP COMMERCIAL LLC · Class I
- MINIGRIP COMMERCIAL — MINIGRIP COMMERCIAL LLC · Class I
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® 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
- Dimension Vista® LOCI® Reaction Vessels — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 9d68f0e4-2c51-445d-8f46-7c0b2d6c5af4 37 fields · synced Jun 8, 2026