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IMMULITE® Systems T3 Calibration Verification Material Total T3
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMULITE® Systems T3 Calibration Verification Material Total T3 FDA UDI
- Generic Name
- Total triiodothyronine (TT3) IVD, control FDA UDI
- Device Name
- Total T3 CVM - IMMULITE - CONS FDA UDI
- Model / Reference
- 10373704 FDA UDI
- Description
- Total T3 CVM - IMMULITE - CONS FDA UDI
Identifiers
- Catalog Number
- LT3CVM FDA UDI
- Primary DI / UDI-DI
- 00630414971360 FDA UDI
- 510(k) Number
- K133124 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Total triiodothyronine (TT3) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Total triiodothyronine (TT3) IVD, control
IMMULITE® Systems T3 Calibration Verification Material Total T3 by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total triiodothyronine (TT3) IVD, control.
- Atellica IM T3 MCM — Siemens Healthcare Diagnostics · Class II
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- ADVIA Centaur® T3 MCM — Siemens Healthcare Diagnostics · Class II
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- ADVIA Centaur® T3 MCM — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K133124 also covers:
- IMMULITE® Systems E2 Calibration Verification Material Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Systems FSH Calibration Verification Material FSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Systems T4 Calibration Verification Material Total T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Systems TBG Calibration Verification Material TBG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 Products Ltd
Sources (1)
- FDA UDI 033337bf-74b6-4342-aa79-d73f75d8d028 37 fields · synced May 30, 2026