Identity
- Trade Name
- Atellica IM TSTII MCM FDA UDI
- Generic Name
- Total testosterone IVD, control FDA UDI
- Device Name
- Testoterone II (TSTII) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL FDA UDI
- Model / Reference
- 10995709 FDA UDI
- Description
- Testoterone II (TSTII) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL FDA UDI
Identifiers
- Catalog Number
- 10995709 FDA UDI
- Primary DI / UDI-DI
- 00630414600239 FDA UDI
- 510(k) Number
- K151986 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Total testosterone 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: Total testosterone IVD, control
Atellica IM TSTII MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total testosterone IVD, control.
- LIAISON® Testosterone Control Set — Diasorin Inc.
- IMMULITE Systems Total Testosterone CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Alinity — Abbott · Class I
- ARCHITECT — Abbott · Class II
- ADVIA Centaur® Testosterone 2 MCM — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K151986 also covers:
- ADVIA Centaur® CAL SHBG — Siemens Healthcare Diagnostics
- ADVIA Centaur® TSTII — Siemens Healthcare Diagnostics
- Atellica IM SHBG — Siemens Healthcare Diagnostics
- Atellica IM SHBG — Siemens Healthcare Diagnostics
- Atellica IM SHBG — Siemens Healthcare Diagnostics
- Atellica IM SHBG Calibrator — Siemens Healthcare Diagnostics
- Atellica IM TSTII — Siemens Healthcare Diagnostics
- Atellica IM TSTII — Siemens Healthcare Diagnostics
- Atellica IM TSTII — 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 1eefbada-b0aa-40aa-a354-9f2f0de379ac 37 fields · synced May 30, 2026