Rapid Response

FDA UDI

Class I (US FDA UDI)

by BTNX Inc

Identity

Trade Name: Rapid Response FDA UDI
Generic Name: Urine analyser IVD, point-of-care FDA UDI
Device Name: Urine Analyzer 120 FDA UDI
Model / Reference: U120 FDA UDI
Description: Urine Analyzer 120 FDA UDI

Identifiers

Primary DI / UDI-DI: 00722066001936 FDA UDI
510(k) Number: K070929 FDA UDI
FDA Product Code: LJX FDA UDI
JRE FDA UDI
JMT FDA UDI
JJB FDA UDI
JIR FDA UDI
JIO FDA UDI
JIN FDA UDI
JIL FDA UDI
CEN FDA UDI
CDM FDA UDI
KQO FDA UDI
GMDN Term: Urine analyser IVD, point-of-care FDA UDI

Classification

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

Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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
Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
My Yodoc — S-CONNECT CO., LTD · Class I
Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System — TECO DIAGNOSTICS · Class I
CLINITEK Status®+ Analyzer — Siemens Healthcare Diagnostics · Class II

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

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Manufacturer

Manufacturer: BTNX Inc

Sources (1)

FDA UDI 77c92f02-79ba-4133-a507-fca511a6cb3d 34 fields · synced May 30, 2026