Identity
- Trade Name
- IMMULITE®/IMMULITE® 1000 Systems TBG FDA UDI
- Generic Name
- Thyroxine binding globulin (TBG) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- TBG - IMMULITE - RGT - 100 Tests FDA UDI
- Model / Reference
- 10381643 FDA UDI
- Description
- TBG - IMMULITE - RGT - 100 Tests FDA UDI
Identifiers
- Catalog Number
- LKTB1 FDA UDI
- Primary DI / UDI-DI
- 00630414964652 FDA UDI
- 510(k) Number
- K950072 FDA UDI
- FDA Product Code
- CEE FDA UDI
- GMDN Term
- Thyroxine binding globulin (TBG) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1685 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: Thyroxine binding globulin (TBG) IVD, kit, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems TBG by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroxine binding globulin (TBG) IVD, kit, chemiluminescent immunoassay.
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 18fd4641-d9f2-462d-bab4-f5d9915d6d3e 37 fields · synced May 30, 2026