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Dimension Vista® Ceruloplasmin Flex® reagent cartridge

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
Dimension Vista® Ceruloplasmin Flex® reagent cartridge FDA UDI
Generic Name
Ceruloplasmin IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
For the quantitative measurement of ceruloplasmin in human serum and plasma on the Dimension Vista® System FDA UDI
Model / Reference
10445892 FDA UDI
Description
For the quantitative measurement of ceruloplasmin in human serum and plasma on the Dimension Vista® System FDA UDI

Identifiers

Catalog Number
K7030 FDA UDI
Primary DI / UDI-DI
00842768006074 FDA UDI
510(k) Number
K063655 FDA UDI
FDA Product Code
CHN FDA UDI
GMDN Term
Ceruloplasmin IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5210 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: Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Dimension Vista® Ceruloplasmin Flex® reagent cartridge by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Ceruloplasmin 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 37ec1f18-4655-45de-b0a3-d4acb1d1da80 37 fields · synced May 31, 2026