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DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, reagent FDA UDI
- Device Name
- For the quantitative measurement of immunoglobulin G subclass 1 in human serum and plasma on the Dimension Vista® System FDA UDI
- Model / Reference
- 10445911 FDA UDI
- Description
- For the quantitative measurement of immunoglobulin G subclass 1 in human serum and plasma on the Dimension Vista® System FDA UDI
Identifiers
- Catalog Number
- K7080 FDA UDI
- Primary DI / UDI-DI
- 00842768006265 FDA UDI
- 510(k) Number
- K092283 FDA UDI
- FDA Product Code
- DFZ FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, reagent 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: Immunoglobulin G subclass (IgG subclass) IVD, reagent
DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Immunoglobulin G subclass (IgG subclass) IVD, reagent.
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- Isotype Reagent Mo IgG1/APC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Isotype Reagent Mo IgG2a/RPE — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- N AS IgG1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N Latex IgG4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
K092283 also covers:
- DImension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- DImension Vista® Immunoglobulin G Subclass 4 Flex® Reagent Cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 8d285fa6-1e8a-49ad-ba90-0bebc8cd8e80 37 fields · synced May 29, 2026