Identity
- Trade Name
- Atellica IM TSTII FDA UDI
- Generic Name
- Total testosterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Testoterone II (TSTII) Atellica IM - RGT 100T FDA UDI
- Model / Reference
- 10995708 FDA UDI
- Description
- Testoterone II (TSTII) Atellica IM - RGT 100T FDA UDI
Identifiers
- Catalog Number
- 10995708 FDA UDI
- Primary DI / UDI-DI
- 00630414600222 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- GMDN Term
- Total testosterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1680 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, kit, chemiluminescent immunoassay
Atellica IM TSTII by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total testosterone IVD, kit, chemiluminescent immunoassay.
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- ARCHITECT — Abbott · Class I
- Elecsys Testosterone II — Roche Diagnostics Corp. · Class I
- FastPack® IP Testo Kit (30) — QUALIGEN INC. · Class I
- Lumipulse G Testosterone Immunoreaction Cartridges — FUJIREBIO INC. · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
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 MCM — 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 65166d4e-31f1-4be6-a688-b978b2d4a63c 37 fields · synced May 31, 2026