Dimension® Flex® reagent cartridge CA

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension® Flex® reagent cartridge CA FDA UDI
Generic Name: Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
Device Name: Calcium Flex® reagent cartridge, 480 tests FDA UDI
Model / Reference: 10444949 FDA UDI
Description: Calcium Flex® reagent cartridge, 480 tests FDA UDI

Identifiers

Catalog Number: DF23A FDA UDI
Primary DI / UDI-DI: 00842768014123 FDA UDI
FDA Product Code: JJE FDA UDI
CIC FDA UDI
GMDN Term: Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 FDA UDI
862.1145 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: Calcium (Ca2+) IVD, kit, spectrophotometry

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

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Also classified as Calcium (Ca2+) IVD, kit, spectrophotometry.

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Calcium Gen2 — Roche Diagnostics Corp. · Class II
CAROLINA LIQUID CHEMISTRIES CORP.™ CALCIUM REAGENT 88815 — Carolina Liquid Chemistries Corp. · Class II
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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 5eb1f2e3-980a-4447-8dc4-09f193e64daf 36 fields · synced May 30, 2026