ADVIA® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents FDA UDI
Generic Name: Glucose IVD, kit, spectrophotometry FDA UDI
Device Name: Glucose - ADVIA Chem. - RGT - 6x660/6x470 tests FDA UDI
Model / Reference: 10335891 FDA UDI
Description: Glucose - ADVIA Chem. - RGT - 6x660/6x470 tests FDA UDI

Identifiers

Catalog Number: 5001429 FDA UDI
Primary DI / UDI-DI: 00630414526812 FDA UDI
510(k) Number: K101854 FDA UDI
FDA Product Code: CFR FDA UDI
GMDN Term: Glucose IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 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: Glucose IVD, kit, spectrophotometry

ADVIA® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Glucose IVD, kit, spectrophotometry.

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Cleared under the same submission

K101854 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 7f57b931-0abb-4ba0-8fd9-76358f51aa9e 37 fields · synced May 30, 2026