Identity
- Trade Name
- Uri-Trak 120 Analyzer FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- The Uri-Trak™ 120 Urine Analyzer is intended for use in conjunction with Stanbio Uri-Chek™ and Uri-Con™ 10 Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. FDA UDI
- Model / Reference
- G1200-001 FDA UDI
- Description
- The Uri-Trak™ 120 Urine Analyzer is intended for use in conjunction with Stanbio Uri-Chek™ and Uri-Con™ 10 Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- G1200-001 FDA UDI
- Primary DI / UDI-DI
- 00657498000076 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Urine analyser IVD, laboratory 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
No
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, laboratory
Uri-Trak 120 Analyzer by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 56f1233d-5533-43cc-becd-f556cab6f05d 35 fields · synced May 30, 2026