Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge KAPPA FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- For the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® System FDA UDI
- Model / Reference
- 10465671 FDA UDI
- Description
- For the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® System FDA UDI
Identifiers
- Catalog Number
- K7049 FDA UDI
- Primary DI / UDI-DI
- 00842768024429 FDA UDI
- 510(k) Number
- K082503 FDA UDI
- FDA Product Code
- DEH FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5550 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: Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Dimension Vista® Flex® reagent cartridge KAPPA by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry.
- Freelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800 — The Binding Site Group · Class II
- Optilite Freelite Kappa Kit — The Binding Site Group · Class II
- Freelite® Human Lambda Free Kit for use on the SPAPLUS — The Binding Site Group · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Freelite® Human Kappa Free Kit for use on the Siemens ADVIA® — The Binding Site Group · Class II
- Optilite Freelite Lambda Kit — The Binding Site Group · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Optilite Freelite Mx Lambda Free Kit — The Binding Site Group · Class II
Cleared under the same submission
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 Products Ltd
Sources (1)
- FDA UDI 1aede223-584f-4937-a4e7-7e54c8a97a07 37 fields · synced Jun 6, 2026