Mckesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name: Mckesson FDA UDI
Generic Name: Urine analyser IVD, point-of-care FDA UDI
Device Name: U120 Touch Urine Analyzer FDA UDI
Model / Reference: 121-120TOUCH FDA UDI
Description: U120 Touch Urine Analyzer FDA UDI

Identifiers

Primary DI / UDI-DI: 10612479279886 FDA UDI
FDA Product Code: JIL FDA UDI
KQO FDA UDI
LJX FDA UDI
CDM FDA UDI
CEN FDA UDI
JIN FDA UDI
JIO FDA UDI
JIR FDA UDI
JJB FDA UDI
JMA FDA UDI
JMT FDA UDI
JRE FDA UDI
GMDN Term: Urine analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1340 FDA UDI
862.2900 FDA UDI
864.7675 FDA UDI
862.1785 FDA UDI
862.1550 FDA UDI
862.1435 FDA UDI
864.6550 FDA UDI
862.1645 FDA UDI
862.1115 FDA UDI
862.1095 FDA UDI
862.1510 FDA UDI
862.2800 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

FDA UDI

Category: Urine analyser IVD, point-of-care

Mckesson by Mckesson Medical-Surgical Inc. — Class II — 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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AIMSTRIP URINE ANALYZER — GERMAINE LABORATORIES, INC. · Class I
CLINITEK Status® Connector — Siemens Healthcare Diagnostics · 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

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: Mckesson Medical-Surgical Inc.

Sources (1)

FDA UDI dbad1ff5-43e0-4874-afb6-96fa9d626ddc 33 fields · synced May 29, 2026