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DImension Vista® Immunoglobulin M Flex® reagent cartridge
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- DImension Vista® Immunoglobulin M Flex® reagent cartridge FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System FDA UDI
- Model / Reference
- 10445904 FDA UDI
- Description
- For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System FDA UDI
Identifiers
- Catalog Number
- K7058 FDA UDI
- Primary DI / UDI-DI
- 00842768006197 FDA UDI
- 510(k) Number
- K090594 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
DImension Vista® Immunoglobulin M Flex® reagent cartridge by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
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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 47ab0832-011a-4321-b2c8-0e491c32f571 37 fields · synced May 30, 2026