CLINITEK Advantus® Analyzer

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: CLINITEK Advantus® Analyzer FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
Device Name: The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Siemens Healthcare Diagnostics Reagent Strips for Urinalysis, such as Multistix® 10 SG and Multistix PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine ratio, Specific Gravity, and Urobilinogen. FDA UDI
Model / Reference: 10636672 FDA UDI
Description: The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Siemens Healthcare Diagnostics Reagent Strips for Urinalysis, such as Multistix® 10 SG and Multistix PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine ratio, Specific Gravity, and Urobilinogen. FDA UDI

Identifiers

Catalog Number: 1420US FDA UDI
Primary DI / UDI-DI: 00630414593562 FDA UDI
510(k) Number: K063276 FDA UDI
FDA Product Code: JIO FDA UDI
JIR FDA UDI
KQO FDA UDI
JIL FDA UDI
JRE FDA UDI
CDM FDA UDI
JIN FDA UDI
JJB FDA UDI
CEN FDA UDI
LJX FDA UDI
JFY FDA UDI
GMDN Term: Urine analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.6550 FDA UDI
862.1645 FDA UDI
862.2900 FDA UDI
862.1340 FDA UDI
862.2800 FDA UDI
862.1785 FDA UDI
862.1435 FDA UDI
862.1115 FDA UDI
862.1550 FDA UDI
864.7675 FDA UDI
862.1225 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Urine analyser IVD, laboratory

CLINITEK Advantus® Analyzer by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 09195209-b04d-4fa1-ae7a-e6c5021f7c44 37 fields · synced May 31, 2026