Identity
- Trade Name
- FT4 Install Kit FDA UDI
- Generic Name
- Free thyroxine (FT4) IVD, control FDA UDI
- Device Name
- Install Kits are unassayed controls intended for use during assay installations for the following analyte: free thyroxine (FT4). FDA UDI
- Model / Reference
- C-1002ro FDA UDI
- Description
- Install Kits are unassayed controls intended for use during assay installations for the following analyte: free thyroxine (FT4). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011135587 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Free thyroxine (FT4) 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Free thyroxine (FT4) IVD, control
FT4 Install Kit by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free thyroxine (FT4) IVD, control.
- Atellica IM FT4 MCM — Siemens Healthcare Diagnostics · Class II
- Alinity — ABBOTT IRELAND · Class I
- IMMULITE® Systems F4 Calibration Verification Material Free T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ADVIA Centaur® FT4 MCM — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- ARCHITECT — ABBOTT IRELAND · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI f30d1dfa-1de3-4494-84c1-26ef97e939ac 35 fields · synced Jun 9, 2026