Uri-Trak 120 M Urine Analyzer

FDA UDI

Class I (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name: Uri-Trak 120 M Urine Analyzer FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
Device Name: The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. 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. FDA UDI
Model / Reference: G1300-001 FDA UDI
Description: The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. 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. FDA UDI

Identifiers

Catalog Number: G1300-001 FDA UDI
Primary DI / UDI-DI: 00657498002094 FDA UDI
FDA Product Code: JIR FDA UDI
KQO FDA UDI
CDM FDA UDI
CEN FDA UDI
JIL FDA UDI
JIN FDA UDI
JIO FDA UDI
JJB FDA UDI
JMT FDA UDI
JRE FDA UDI
LJX FDA UDI
JMA FDA UDI
GMDN Term: Urine analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1645 FDA UDI
862.2900 FDA UDI
862.1785 FDA UDI
862.1550 FDA UDI
862.1340 FDA UDI
862.1435 FDA UDI
864.6550 FDA UDI
862.1115 FDA UDI
862.1510 FDA UDI
862.2800 FDA UDI
864.7675 FDA UDI
862.1095 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Urine analyser IVD, laboratory

Uri-Trak 120 M Urine 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 8f057c17-c18a-4bf1-a883-ca7ac1c6ba9e 35 fields · synced May 30, 2026