Identity
- Trade Name
- Detector UA 5 FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed FDA UDI
- Model / Reference
- IDU-5OB FDA UDI
- Description
- Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722355002238 FDA UDI
- 510(k) Number
- K970250 FDA UDI
- FDA Product Code
- JIO FDA UDIJIR FDA UDILJX FDA UDIJMT FDA UDIJIL FDA UDI
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6550 FDA UDI862.1645 FDA UDI864.7675 FDA UDI862.1510 FDA UDI862.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Detector UA 5 by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class II
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- URiSCAN 1 Glucose strip — Yd Diagnostics · Class II
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class I
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Moore Medical — Moore Medical Corp. · Class I
Cleared under the same submission
K970250 also covers:
- Detector UA 10 — IMMUNOSTICS, INC.
- Urine Reagent Strips, 10-parameter — LW SCIENTIFIC, INC.
- Urine Reagent Strips, 5-parameter — LW SCIENTIFIC, INC.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immunostics, Inc.
Sources (1)
- FDA UDI 50a038f0-7b5a-4dc6-b859-2ccae7745ad7 36 fields · synced Jun 6, 2026