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Dimension Vista® Total Testosterone Flex® Reagent Cartridge

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Total Testosterone Flex® Reagent Cartridge FDA UDI
Generic Name
Total testosterone IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
LOCI Total Testosterone Flex® reagent cartridge, 320 tests FDA UDI
Model / Reference
10488399 FDA UDI
Description
LOCI Total Testosterone Flex® reagent cartridge, 320 tests FDA UDI

Identifiers

Catalog Number
K6465 FDA UDI
Primary DI / UDI-DI
00842768026485 FDA UDI
510(k) Number
K151529 FDA UDI
FDA Product Code
CDZ FDA UDI
GMDN Term
Total testosterone IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1680 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: Total testosterone IVD, kit, chemiluminescent immunoassay

Dimension Vista® Total Testosterone Flex® Reagent Cartridge by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Total testosterone IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K151529 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 93c22e77-3602-4a31-a928-c9ddca4b0cc5 37 fields · synced May 29, 2026