Identity
- Trade Name
- Atellica IM Zika Ab 100T FDA UDI
- Generic Name
- Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Zika Ab tellica IM Assay Kit 100T FDA UDI
- Model / Reference
- 11204647 FDA UDI
- Description
- Zika Ab tellica IM Assay Kit 100T FDA UDI
Identifiers
- Catalog Number
- 11204647 FDA UDI
- Primary DI / UDI-DI
- 00630414286853 FDA UDI
- 510(k) Number
- K191578 FDA UDI
- FDA Product Code
- QFO FDA UDI
- GMDN Term
- Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3935 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: Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Atellica IM Zika Ab 100T by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.
- LIAISON® XL Zika Capture IgM II — Diasorin Inc. · Class II
- Atellica IM Zika IgM 50T — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur Zika Ab 100T — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur Zika IgM 50T — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K191578 also covers:
- ADVIA Centaur Zika Ab 100T — Siemens Healthcare Diagnostics
- ADVIA Centaur Zika Ab QC — Siemens Healthcare Diagnostics
- ADVIA Centaur Zika IgM 50T — Siemens Healthcare Diagnostics
- ADVIA Centaur Zika IgM QC — Siemens Healthcare Diagnostics
- Atellica IM Zika Ab QC — Siemens Healthcare Diagnostics
- Atellica IM Zika IgM 50T — Siemens Healthcare Diagnostics
- Atellica IM Zika IgM Controls — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI b556d527-0406-47fd-adf8-a38ba9ebe1cf 37 fields · synced Jun 8, 2026