CLINITEK Status®+ Analyzer

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: CLINITEK Status®+ Analyzer FDA UDI
Generic Name: Urine analyser IVD, point-of-care FDA UDI
Device Name: The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). FDA UDI
Model / Reference: 10379675 FDA UDI
Description: The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). FDA UDI

Identifiers

Catalog Number: 10379675 FDA UDI
Primary DI / UDI-DI: 00630414574639 FDA UDI
510(k) Number: K091216 FDA UDI
FDA Product Code: JFY FDA UDI
CDM FDA UDI
CEN FDA UDI
JIL FDA UDI
JHI FDA UDI
JIN FDA UDI
JIP FDA UDI
JMT FDA UDI
JJB FDA UDI
LJX FDA UDI
JRE FDA UDI
JIR FDA UDI
KQO FDA UDI
GMDN Term: Urine analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1225 FDA UDI
862.1785 FDA UDI
862.1550 FDA UDI
862.1340 FDA UDI
862.1155 FDA UDI
862.1435 FDA UDI
864.6550 FDA UDI
862.1510 FDA UDI
862.1115 FDA UDI
864.7675 FDA UDI
862.2800 FDA UDI
862.1645 FDA UDI
862.2900 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, point-of-care

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

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Cleared under the same submission

K091216 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 d5b9cb4a-afc0-45ef-9062-d2c33fc83550 37 fields · synced Jun 8, 2026