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Dimension Vista® Flex® reagent cartridge GGT

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Flex® reagent cartridge GGT FDA UDI
Generic Name
Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
Device Name
Gamma Glutamyl Transferase Flex® reagent cartridge, 420 tests FDA UDI
Model / Reference
10445150 FDA UDI
Description
Gamma Glutamyl Transferase Flex® reagent cartridge, 420 tests FDA UDI

Identifiers

Catalog Number
K2045 FDA UDI
Primary DI / UDI-DI
00842768015229 FDA UDI
510(k) Number
K061655 FDA UDI
FDA Product Code
JQB FDA UDI
GMDN Term
Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1360 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: Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge GGT by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry.

Cleared under the same submission

K061655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 7481b565-d5b6-45a0-acea-992a28f47fa0 37 fields · synced May 30, 2026