Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge CA15-3 FDA UDI
- Generic Name
- Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- LOCI CA 15-3 Flex® reagent cartridge, 160 Tests FDA UDI
- Model / Reference
- 10464344 FDA UDI
- Description
- LOCI CA 15-3 Flex® reagent cartridge, 160 Tests FDA UDI
Identifiers
- Catalog Number
- K6456 FDA UDI
- Primary DI / UDI-DI
- 00842768028526 FDA UDI
- 510(k) Number
- K100344 FDA UDI
- FDA Product Code
- MOI FDA UDI
- GMDN Term
- Cancer antigen 15-3 (CA15-3) 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 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Dimension Vista® Flex® reagent cartridge CA15-3 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay.
- Alinity — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Lumipulse G CA 15-3 Immunoreaction Cartridges — FUJIREBIO INC.
- VITROS — Ortho-Clinical Diagnostics · Class II
- ARCHITECT — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Alinity — Abbott · Class II
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 704d17be-2cd0-4a0e-91cf-9e4f23aad6b0 37 fields · synced May 30, 2026