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+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect system. FDA UDI
Model / Reference: 11537761 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+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect system. FDA UDI

Identifiers

Catalog Number: 11537761 FDA UDI
Primary DI / UDI-DI: 00630414607962 FDA UDI
510(k) Number: K091216 FDA UDI
FDA Product Code: JJB FDA UDI
JIR FDA UDI
CEN FDA UDI
JFY FDA UDI
CDM FDA UDI
JMT FDA UDI
JHI FDA UDI
JIN FDA UDI
KQO FDA UDI
JIP FDA UDI
JRE FDA UDI
LJX FDA UDI
GMDN Term: Urine analyser IVD, point-of-care FDA UDI

Classification

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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

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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Also classified as Urine analyser IVD, point-of-care.

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Rapid Response — BTNX Inc · Class I
Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
Rapid Response — BTNX Inc · Class I
Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
My Yodoc — S-CONNECT CO., LTD · Class I

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 80ef26a6-cc56-4442-b9df-1f76c69b7c06 37 fields · synced May 31, 2026