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Dimension Vista® Flex® reagent cartridge BENZ

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Flex® reagent cartridge BENZ FDA UDI
Generic Name
Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Urine Benzodiazepines Screen Flex® reagent cartridge, 120 tests FDA UDI
Model / Reference
10445118 FDA UDI
Description
Urine Benzodiazepines Screen Flex® reagent cartridge, 120 tests FDA UDI

Identifiers

Catalog Number
K5097 FDA UDI
Primary DI / UDI-DI
00842768015083 FDA UDI
510(k) Number
K062128 FDA UDI
FDA Product Code
JXM FDA UDI
GMDN Term
Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3170 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: Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Benzodiazepine group IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K062128 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 429a1708-3e00-48f6-a0cb-358b6846c7dd 37 fields · synced May 30, 2026