Identity
- Trade Name
- Atellica IM CA 19-9 FDA UDI
- Generic Name
- Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- CA 19-9 Atellica IM - RGT 250T FDA UDI
- Model / Reference
- 10995489 FDA UDI
- Description
- CA 19-9 Atellica IM - RGT 250T FDA UDI
Identifiers
- Catalog Number
- 10995489 FDA UDI
- Primary DI / UDI-DI
- 00630414598161 FDA UDI
- 510(k) Number
- K031393 FDA UDI
- FDA Product Code
- NIG FDA UDI
- GMDN Term
- Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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: Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
Atellica IM CA 19-9 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay.
- Alinity — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ARCHITECT — Abbott · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
- Atellica IM CA 19-9 — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K031393 also covers:
- ADVIA Centaur® CA 19-9 DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® CA 19-9 MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® CA 19-9™ — Siemens Healthcare Diagnostics
- ADVIA Centaur® CA 19-9™ — Siemens Healthcare Diagnostics
- ADVIA Centaur® CA 19-9™ DIL — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 DIL — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI f900e35d-a993-4ae0-9002-715e9a9c0e41 37 fields · synced May 30, 2026