Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Urine analyser IVD, point-of-care FDA UDI
- Device Name
- The Rapid Response® U121S Urine Analyzer is intended for use in conjunction with the Rapid Response® Urinalysis Reagent Strips for the semi-quantitative detection of analytes in human urine. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. The instrument is intended for professional, in vitro diagnostic use only. FDA UDI
- Model / Reference
- UA-U121S FDA UDI
- Description
- The Rapid Response® U121S Urine Analyzer is intended for use in conjunction with the Rapid Response® Urinalysis Reagent Strips for the semi-quantitative detection of analytes in human urine. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. The instrument is intended for professional, in vitro diagnostic use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722066004415 FDA UDI
- 510(k) Number
- K120124 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Urine analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
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.
- HemoCue® Urine Albumin Microcuvettes — Hemocue, Inc. · Class I
- 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
Cleared under the same submission
K120124 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 |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI cdaa4340-fd4d-4a20-8533-00c1b4d45ff1 34 fields · synced May 30, 2026