Identity
- Trade Name
- Detector UA 2GP FDA UDI
- Generic Name
- Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- For rapid detection of multiple analytes in human urine. FDA UDI
- Model / Reference
- IDU-2GP FDA UDI
- Description
- For rapid detection of multiple analytes in human urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722355002917 FDA UDI
- FDA Product Code
- JIL FDA UDIJIO FDA UDILJX FDA UDICDM FDA UDICEN FDA UDIJIR FDA UDIJRE FDA UDIJIN FDA UDIJMT FDA UDIJJB FDA UDIJMA FDA UDI
- GMDN Term
- Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1340 FDA UDI864.6550 FDA UDI864.7675 FDA UDI862.1785 FDA UDI862.1550 FDA UDI862.1645 FDA UDI862.2800 FDA UDI862.1435 FDA UDI862.1510 FDA UDI862.1115 FDA UDI862.1095 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: Urine glucose IVD, kit, rapid colorimetric, clinicalUrine protein IVD, kit, rapid colorimetric, clinical
Detector UA 2GP by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine protein IVD, kit, rapid colorimetric, clinical.
- Clinistix Kidney Health Test System — Siemens Healthcare Diagnostics · Class II
- Tanner Scientific® — MERCEDES MEDICAL LLC · Class I
- Rapid Response — BTNX Inc · Class II
- Rapid Response — BTNX Inc · Class I
- Rapid Response — BTNX Inc · Class II
- Rapid Response — BTNX Inc · Class I
- AIMSTRIP US-4OB — GERMAINE LABORATORIES, INC. · Class I
- Rapid Response — BTNX 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immunostics, Inc.
Sources (1)
- FDA UDI cf1829dc-ca1e-4e30-8919-f13f39ffa8ae 35 fields · synced Jun 8, 2026