Clinitek Novus® Rinse Additive

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Clinitek Novus® Rinse Additive FDA UDI
Generic Name: Buffered wash solution IVD FDA UDI
Device Name: Rinse additive for CLINITEK Novus® automated urine chemistry system. FDA UDI
Model / Reference: 10697754 FDA UDI
Description: Rinse additive for CLINITEK Novus® automated urine chemistry system. FDA UDI

Identifiers

Catalog Number: 10697754 FDA UDI
Primary DI / UDI-DI: 00630414590936 FDA UDI
510(k) Number: K140717 FDA UDI
FDA Product Code: JIL FDA UDI
JMT FDA UDI
JRE FDA UDI
JIO FDA UDI
CDM FDA UDI
JIR FDA UDI
JJB FDA UDI
CEN FDA UDI
JIN FDA UDI
KQO FDA UDI
JIX FDA UDI
LJX FDA UDI
GMDN Term: Buffered wash solution IVD FDA UDI

Classification

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Buffered wash solution IVD

Clinitek Novus® Rinse Additive by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Buffered wash solution IVD.

CELL-DYN — Abbott Laboratories, Inc. · Class I
VENTANA HE 600 Wash — Ventana Medical Systems · Class I
TBS Auto Wash Buffer 20X — BIOCARE MEDICAL, LLC · Class I
COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
V8 Maintenance Buffer Kit — Helena Laboratories, Corp. · Class I
Genemed® — Sakura Finetek USA, Inc · Class I
cobas&#x00AE Sample Prep Buffer — Roche Molecular Systems, Inc. · Class I

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 II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 2bff062c-f08c-4c1c-854c-542c234208ff 37 fields · synced May 30, 2026