Dimension Vista® Flex® reagent cartridge AMM

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension Vista® Flex® reagent cartridge AMM FDA UDI
Generic Name: Ammonia IVD, kit, spectrophotometry FDA UDI
Device Name: Ammonia Flex® reagent cartridge, 120 tests FDA UDI
Model / Reference: 10711992 FDA UDI
Description: Ammonia Flex® reagent cartridge, 120 tests FDA UDI

Identifiers

Catalog Number: K3119 FDA UDI
Primary DI / UDI-DI: 00630414948102 FDA UDI
510(k) Number: K123677 FDA UDI
FDA Product Code: JIF FDA UDI
GMDN Term: Ammonia IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1065 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ammonia IVD, kit, spectrophotometry

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

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ADVIA® Chemistry AMM Ammonia Reagents — Siemens Healthcare Diagnostics · Class I
Dimension® Flex® reagent cartridge AMM — Siemens Healthcare Diagnostics · Class I
Atellica CH Amm — Siemens Healthcare Diagnostics · Class I

Cleared under the same submission

K123677 also covers:

Dimension Vista® CHEM 3 CAL — Siemens Healthcare Diagnostics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 6cf38ef0-63a3-4878-8a8a-01b7df08c7ae 37 fields · synced May 30, 2026