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DImension Vista® Immunoglobulin E Flex® reagent cartridge

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
DImension Vista® Immunoglobulin E Flex® reagent cartridge FDA UDI
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System FDA UDI
Model / Reference
10445902 FDA UDI
Description
For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System FDA UDI

Identifiers

Catalog Number
K7054 FDA UDI
Primary DI / UDI-DI
00842768006173 FDA UDI
510(k) Number
K063425 FDA UDI
FDA Product Code
DGC FDA UDI
GMDN Term
Allergen-specific immunoglobulin E (IgE) antibody 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: Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin E Flex® reagent cartridge by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 8f64b2d0-017c-4ed7-93a0-9af4964283e8 37 fields · synced May 30, 2026