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DImension Vista® Prealbumin Flex® reagent cartridge

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
DImension Vista® Prealbumin Flex® reagent cartridge FDA UDI
Generic Name
Collagen pyridium crosslink IVD, reagent FDA UDI
Device Name
For the quantitative measurement of Prealbumin in human serum and plasma on the Dimension Vista® System FDA UDI
Model / Reference
10445906 FDA UDI
Description
For the quantitative measurement of Prealbumin in human serum and plasma on the Dimension Vista® System FDA UDI

Identifiers

Catalog Number
K7064 FDA UDI
Primary DI / UDI-DI
00842768006210 FDA UDI
FDA Product Code
JZJ FDA UDI
GMDN Term
Collagen pyridium crosslink IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.5060 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Collagen pyridium crosslink IVD, reagent

DImension Vista® Prealbumin Flex® reagent cartridge by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Collagen pyridium crosslink IVD, reagent.

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 c3d53c8f-72ea-46c1-b9ef-ec93d566b1be 36 fields · synced Jun 6, 2026