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CLINITEK Novus® 10 Urinalysis Cassette 450

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
CLINITEK Novus® 10 Urinalysis Cassette 450 FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Cassette to be used on the CLINITEK Novus system for determination of 10 parameters. 450 tests guaranteed per cassette FDA UDI
Model / Reference
10634643 FDA UDI
Description
Cassette to be used on the CLINITEK Novus system for determination of 10 parameters. 450 tests guaranteed per cassette FDA UDI

Identifiers

Catalog Number
10634643 FDA UDI
Primary DI / UDI-DI
00630414602653 FDA UDI
510(k) Number
K140717 FDA UDI
FDA Product Code
JIL FDA UDI
JRE FDA UDI
CDM FDA UDI
CEN FDA UDI
LJX FDA UDI
JIR FDA UDI
JIN FDA UDI
JIO FDA UDI
JMT FDA UDI
KQO FDA UDI
JJB FDA UDI
JIX FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1340 FDA UDI
862.2800 FDA UDI
862.1785 FDA UDI
862.1550 FDA UDI
864.7675 FDA UDI
862.1645 FDA UDI
862.1435 FDA UDI
864.6550 FDA UDI
862.1510 FDA UDI
862.2900 FDA UDI
862.1115 FDA UDI
862.1150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical

CLINITEK Novus® 10 Urinalysis Cassette 450 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K140717 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 492587a2-2647-481c-b6e9-b6877c7935e1 37 fields · synced May 30, 2026