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Tanner Scientific®

FDA UDI

Class I (US FDA UDI)

by Mercedes Medical Llc

Identity

Trade Name
Tanner Scientific® FDA UDI
Generic Name
Urine glucose IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase FDA UDI
Model / Reference
TNR 10SG FDA UDI
Description
Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase FDA UDI

Identifiers

Catalog Number
TNR 10SG FDA UDI
Primary DI / UDI-DI
00850011007143 FDA UDI
FDA Product Code
LJX FDA UDI
JMT FDA UDI
JMA FDA UDI
JJB FDA UDI
JIR FDA UDI
JIN FDA UDI
JIL FDA UDI
CEN FDA UDI
CDM FDA UDI
JIO FDA UDI
GMDN Term
Urine glucose IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.7675 FDA UDI
862.1510 FDA UDI
862.1095 FDA UDI
862.1115 FDA UDI
862.1645 FDA UDI
862.1435 FDA UDI
862.1340 FDA UDI
862.1550 FDA UDI
862.1785 FDA UDI
864.6550 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

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

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, clinicalUrine glucose IVD, kit, rapid colorimetric, clinicalUrine ketone IVD, kit, rapid colorimetric, clinicalUrine protein IVD, kit, rapid colorimetric, clinical

Tanner Scientific® by Mercedes Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine creatinine IVD, kit, rapid colorimetric, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mercedes Medical Llc

Sources (1)

  • FDA UDI 5c0f001f-c048-4b0f-bd49-f89eb245b0cd 36 fields · synced May 30, 2026