CLINITEK Novus® Automated Urine Chemistry Analyzer

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: CLINITEK Novus® Automated Urine Chemistry Analyzer FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
Device Name: The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu FDA UDI
Model / Reference: 10697937 FDA UDI
Description: The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu FDA UDI

Identifiers

Catalog Number: 10697937 FDA UDI
Primary DI / UDI-DI: 00630414981147 FDA UDI
510(k) Number: K140717 FDA UDI
FDA Product Code: JIR FDA UDI
JIN FDA UDI
JRE FDA UDI
JJB FDA UDI
JMT FDA UDI
CEN FDA UDI
JIL FDA UDI
KQO FDA UDI
CDM FDA UDI
JIO FDA UDI
JIX FDA UDI
LJX FDA UDI
GMDN Term: Urine analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1645 FDA UDI
862.1435 FDA UDI
862.2800 FDA UDI
862.1115 FDA UDI
862.1510 FDA UDI
862.1550 FDA UDI
862.1340 FDA UDI
862.2900 FDA UDI
862.1785 FDA UDI
864.6550 FDA UDI
862.1150 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

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

FDA UDI

Category: Urine analyser IVD, laboratory

CLINITEK Novus® Automated Urine Chemistry Analyzer by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine analyser IVD, laboratory.

McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Uri-Trak 120 Analyzer — STANBIO LABORATORY, L.P. · Class I
Urisys 1100 Urine Analyzer — Roche Diagnostics Corp. · Class II
UA Win10 Kit — BECKMAN COULTER IRELAND INC. · Class I
Moore Medical — Moore Medical Corp. · Class II
AUTION EYE™ Control Solution H/L — ARKRAY USA, INC. · Class I
AUTION™ Diluent SED — ARKRAY USA, INC. · Class I
Moore Medical — Moore Medical Corp. · Class II

Cleared under the same submission

K140717 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI be4f0e02-227c-4d5b-8eab-ab0637f85cf6 37 fields · synced Jun 8, 2026