Identity
- Trade Name
- Atellica IM AFP FDA UDI
- Generic Name
- Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 500T FDA UDI
- Model / Reference
- 11202258 FDA UDI
- Description
- Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 500T FDA UDI
Identifiers
- Catalog Number
- 11202258 FDA UDI
- Primary DI / UDI-DI
- 00630414238807 FDA UDI
- PMA Number
- P930036 FDA UDI
- FDA Product Code
- LOK FDA UDI
- GMDN Term
- Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class III 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: Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Atellica IM AFP by Siemens Healthcare Diagnostics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay.
- VITROS — Ortho-Clinical Diagnostics · Class II
- Elecsys AFP — Roche Diagnostics Corp. · Class II
- IMMULITE®/IMMULITE®1000 Systems AF AFP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- Monobind AccuLite AFP CLIA Kit - 192 Wells — MONOBIND, INC. · Class II
- IMMULITE® 2000 Systems AF AFP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- ARCHITECT — Abbott Ireland Diagnostics · Class III
- VITROS — Ortho-Clinical Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class III
Cleared under the same submission
P930036 also covers:
- ADVIA Centaur® AFP — Siemens Healthcare Diagnostics
- ADVIA Centaur® Calibrator D — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS 180® Systems AFP MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator D — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator D — Siemens Healthcare Diagnostics
- Atellica IM AFP — Siemens Healthcare Diagnostics
- Atellica IM AFP MCM — Siemens Healthcare Diagnostics
- Atellica IM Calibrator D — Siemens Healthcare Diagnostics
- Atellica IM Calibrator D — Siemens Healthcare Diagnostics
- Atellica IM Calibrator D — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2ac82c75-92cb-4a80-a286-112190c6db86 37 fields · synced Jun 6, 2026