Identity
- Trade Name
- MAGLUMI 2000 FT4 FDA UDI
- Generic Name
- Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 130203016M FDA UDI
Identifiers
- Catalog Number
- 130203016M FDA UDI
- Primary DI / UDI-DI
- 06947145577988 FDA UDI
- 510(k) Number
- K182423 FDA UDI
- FDA Product Code
- CEC FDA UDI
- GMDN Term
- Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1695 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
Yes
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: Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Maglumi 2000 Ft4 by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay.
- Atellica IM FT4 — Siemens Healthcare Diagnostics · Class II
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- VITROS — Ortho-Clinical Diagnostics · Class I
- Monobind AccuLite Free T4 CLIA Kit - 960 Wells — MONOBIND, INC. · Class II
- Alinity — ABBOTT IRELAND · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ADVIA Centaur® FT4 — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K182423 also covers:
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
Sources (1)
- FDA UDI be828cb7-d246-4e0c-a9ee-354bb48000fb 35 fields · synced May 30, 2026