Identity
- Trade Name
- IMMULITE® Systems TSH CONTROL Third Generation TSH FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, control FDA UDI
- Device Name
- TSH 3rd Gen - IMMULITE - CONS - 2x2.0mL FDA UDI
- Model / Reference
- 10385395 FDA UDI
- Description
- TSH 3rd Gen - IMMULITE - CONS - 2x2.0mL FDA UDI
Identifiers
- Catalog Number
- LTGCM FDA UDI
- Primary DI / UDI-DI
- 00630414953311 FDA UDI
- 510(k) Number
- K930007 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) 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: Thyroid stimulating hormone (TSH) IVD, control
IMMULITE® Systems TSH CONTROL Third Generation TSH by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
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- Validate — LGC Clinical Diagnostics, Inc. · Class I
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 Products Ltd
Sources (1)
- FDA UDI ad49c653-12b1-4d4e-b756-f1c41bf7c849 37 fields · synced May 30, 2026