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IMMULITE® Systems TSH Calibration Verification Material TSH
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE® Systems TSH Calibration Verification Material TSH FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, control FDA UDI
- Device Name
- TSH CVM - IMMULITE - CONS FDA UDI
- Model / Reference
- 10388157 FDA UDI
- Description
- TSH CVM - IMMULITE - CONS FDA UDI
Identifiers
- Catalog Number
- LTSCVM FDA UDI
- Primary DI / UDI-DI
- 00630414979458 FDA UDI
- 510(k) Number
- K910981 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1690 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: Thyroid stimulating hormone (TSH) IVD, control
IMMULITE® Systems TSH Calibration Verification Material TSH by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Thyroid stimulating hormone (TSH) IVD, control.
- Atellica IM TSH3-UL MCM — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® TSH3-UL MCM — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® TSH MCM — Siemens Healthcare Diagnostics · Class II
- TSH Control Slides — BIO SB, INC. · Class I
- TSH control slides — BIO SB, INC. · Class I
- ARCHITECT — ABBOTT IRELAND · Class II
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
Cleared under the same submission
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 Products Ltd
Sources (1)
- FDA UDI ba005d63-54ee-4d3d-afec-3f4d36caa130 37 fields · synced Jun 8, 2026