Identity
- Trade Name
- Atellica IM FT3 MCM FDA UDI
- Generic Name
- Free triiodothyronine (FT3) IVD, control FDA UDI
- Device Name
- Free T3 (FT3) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL FDA UDI
- Model / Reference
- 10995586 FDA UDI
- Description
- Free T3 (FT3) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL FDA UDI
Identifiers
- Catalog Number
- 10995586 FDA UDI
- Primary DI / UDI-DI
- 00630414599106 FDA UDI
- 510(k) Number
- K991692 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Free triiodothyronine (FT3) 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
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 triiodothyronine (FT3) IVD, control
Atellica IM FT3 MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free triiodothyronine (FT3) IVD, control.
- ARCHITECT — ABBOTT IRELAND · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- ARCHITECT — ABBOTT IRELAND · Class II
- IMMULITE® Systems FT3 Calibration Verification Material Free T3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Alinity — ABBOTT IRELAND · Class I
- ADVIA Centaur® FT3 MCM — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K991692 also covers:
- ADVIA Centaur® FT3 — Siemens Healthcare Diagnostics
- ADVIA Centaur® FT3 — Siemens Healthcare Diagnostics
- ADVIA Centaur® FT3 — Siemens Healthcare Diagnostics
- ADVIA Centaur® FT3 MCM — Siemens Healthcare Diagnostics
- Atellica IM FT3 — Siemens Healthcare Diagnostics
- Atellica IM FT3 — Siemens Healthcare Diagnostics
- Atellica IM FT3 — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 5fefd03b-fb2f-4138-b9db-7449f764a2a4 37 fields · synced May 30, 2026