Identity
- Trade Name
- Atellica IM TSH3-UL MCM FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, control FDA UDI
- Device Name
- TSH3-UL Atellica IM - Master Curve Material Kit 10 x 1 x 2.0mL FDA UDI
- Model / Reference
- 10995705 FDA UDI
- Description
- TSH3-UL Atellica IM - Master Curve Material Kit 10 x 1 x 2.0mL FDA UDI
Identifiers
- Catalog Number
- 10995705 FDA UDI
- Primary DI / UDI-DI
- 00630414600185 FDA UDI
- 510(k) Number
- K150403 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
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: Thyroid stimulating hormone (TSH) IVD, control
Atellica IM TSH3-UL MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid stimulating hormone (TSH) IVD, control.
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- IMMULITE® Systems TSH CONTROL Third Generation TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — ABBOTT IRELAND · Class II
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- TSH Control Slides — BIO SB, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI b2c4be2b-6cf4-4392-a4bd-ad8dd621e1c4 37 fields · synced May 30, 2026