Identity
- Trade Name
- Dimension Vista® Testosterone Calibrator FDA UDI
- Generic Name
- Total testosterone IVD, calibrator FDA UDI
- Device Name
- Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL; 2D x 1.0 mL; 2E x 1.0 mL; 2F x 1.0 mL) FDA UDI
- Model / Reference
- 10712611 FDA UDI
- Description
- Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL; 2D x 1.0 mL; 2E x 1.0 mL; 2F x 1.0 mL) FDA UDI
Identifiers
- Catalog Number
- KC638 FDA UDI
- Primary DI / UDI-DI
- 00630414948775 FDA UDI
- 510(k) Number
- K151529 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Total testosterone IVD, calibrator 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
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: Total testosterone IVD, calibrator
Dimension Vista® Testosterone Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total testosterone IVD, calibrator.
- Lumipulse G Testosterone Calibrators — FUJIREBIO INC. · Class II
- ARCHITECT — Abbott · Class I
- Alinity — Abbott · Class II
- Calibrator Kit - Testosterone — QUALIGEN INC. · Class II
Cleared under the same submission
K151529 also covers:
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 36b7294c-8e8d-4c49-8206-3ff7e50bdfab 37 fields · synced May 30, 2026