ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo III

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo III FDA UDI
Generic Name: Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
Device Name: Calcium - ADVIA Chem. - RGT - 4x1700 tests FDA UDI
Model / Reference: 10283344 FDA UDI
Description: Calcium - ADVIA Chem. - RGT - 4x1700 tests FDA UDI

Identifiers

Catalog Number: 6860493 FDA UDI
Primary DI / UDI-DI: 00630414553160 FDA UDI
510(k) Number: K083386 FDA UDI
FDA Product Code: CJY FDA UDI
GMDN Term: Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo III by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID

Similar devices

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
Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II

Cleared under the same submission

K083386 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 ac026718-0322-49c1-8b65-e46c30ae404b 37 fields · synced May 30, 2026