CLINITEK Status®+ Analyzer

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: CLINITEK Status®+ Analyzer FDA UDI
Generic Name: Urine analyser IVD, point-of-care FDA UDI
Device Name: The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). FDA UDI
Model / Reference: 10379677 FDA UDI
Description: The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). FDA UDI

Identifiers

Catalog Number: 10379677 FDA UDI
Primary DI / UDI-DI: 00630414572314 FDA UDI
510(k) Number: K091216 FDA UDI
FDA Product Code: CDM FDA UDI
JMT FDA UDI
JFY FDA UDI
LJX FDA UDI
KQO FDA UDI
JRE FDA UDI
CEN FDA UDI
JIN FDA UDI
JIR FDA UDI
JJB FDA UDI
JIL FDA UDI
JIP FDA UDI
JHI FDA UDI
GMDN Term: Urine analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1785 FDA UDI
862.1510 FDA UDI
862.1225 FDA UDI
864.7675 FDA UDI
862.2900 FDA UDI
862.2800 FDA UDI
862.1550 FDA UDI
862.1435 FDA UDI
862.1645 FDA UDI
862.1115 FDA UDI
862.1340 FDA UDI
864.6550 FDA UDI
862.1155 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, point-of-care

CLINITEK Status®+ 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, point-of-care.

HemoCue® Urine Albumin Microcuvettes — Hemocue, Inc. · Class I
Rapid Response — BTNX Inc · Class I
AIMSTRIP URINE ANALYZER — GERMAINE LABORATORIES, INC. · Class I
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

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

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI cd3525c1-ca59-4a57-a716-e6e03a02dc51 37 fields · synced May 30, 2026