CLINITEK Status® Connector

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: CLINITEK Status® Connector FDA UDI
Generic Name: Urine analyser IVD, point-of-care FDA UDI
Device Name: The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR). FDA UDI
Model / Reference: 10376323 FDA UDI
Description: The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR). FDA UDI

Identifiers

Catalog Number: 10376323 FDA UDI
Primary DI / UDI-DI: 00630414578330 FDA UDI
510(k) Number: K091216 FDA UDI
FDA Product Code: CEN FDA UDI
JIP FDA UDI
JHI FDA UDI
CDM FDA UDI
KQO FDA UDI
LJX FDA UDI
JIN FDA UDI
JMT FDA UDI
JRE FDA UDI
JJB FDA UDI
JIR FDA UDI
JIL FDA UDI
JFY FDA UDI
GMDN Term: Urine analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1550 FDA UDI
864.6550 FDA UDI
862.1155 FDA UDI
862.1785 FDA UDI
862.2900 FDA UDI
864.7675 FDA UDI
862.1435 FDA UDI
862.1510 FDA UDI
862.2800 FDA UDI
862.1115 FDA UDI
862.1645 FDA UDI
862.1340 FDA UDI
862.1225 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

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® Connector by Siemens Healthcare Diagnostics — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI bec62ad8-a7cc-4b80-8110-da2acc268ce8 37 fields · synced May 29, 2026