Dimension Vista® Flex® reagent cartridge AMY

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension Vista® Flex® reagent cartridge AMY FDA UDI
Generic Name: Total amylase IVD, kit, spectrophotometry FDA UDI
Device Name: Amylase Flex® reagent cartridge, 360 tests FDA UDI
Model / Reference: 10445154 FDA UDI
Description: Amylase Flex® reagent cartridge, 360 tests FDA UDI

Identifiers

Catalog Number: K3017 FDA UDI
Primary DI / UDI-DI: 00842768015069 FDA UDI
510(k) Number: K061655 FDA UDI
FDA Product Code: JFJ FDA UDI
GMDN Term: Total amylase IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1070 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: Total amylase IVD, kit, spectrophotometry

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

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Also classified as Total amylase IVD, kit, spectrophotometry.

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Pointe Amylase on BS480 Analyzer — POINTE SCIENTIFIC, INC. · Class II

Cleared under the same submission

K061655 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 615d89de-ec6f-481d-9e4e-04ecc04721c4 37 fields · synced Jun 6, 2026