Identity
- Trade Name
- Atellica IM CA 15-3 MCM FDA UDI
- Generic Name
- Cancer antigen 15-3 (CA15-3) IVD, control FDA UDI
- Device Name
- CA 15-3 Atellica IM Master Curve Material Kit 7 x 1 x 1.0mL FDA UDI
- Model / Reference
- 10995488 FDA UDI
- Description
- CA 15-3 Atellica IM Master Curve Material Kit 7 x 1 x 1.0mL FDA UDI
Identifiers
- Catalog Number
- 10995488 FDA UDI
- Primary DI / UDI-DI
- 00630414598154 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Cancer antigen 15-3 (CA15-3) 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: Cancer antigen 15-3 (CA15-3) IVD, control
Atellica IM CA 15-3 MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 15-3 (CA15-3) IVD, control.
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- Alinity — Abbott · Class I
- AIA-PACK 27.29 Calibrator Set — Tosoh Corp. · Class II
- ARCHITECT — Abbott · Class I
- ADVIA Centaur® CA 15-3® MCM — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K012357 also covers:
- ADVIA Centaur® CA 15-3® — Siemens Healthcare Diagnostics
- ADVIA Centaur® CA 15-3® MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems CA 15-3® Calibrator — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3 — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3 — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3 — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3® Calibrator — 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 312f5b2a-3d9e-4257-a7ce-8b4406ebc1f9 37 fields · synced May 30, 2026