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ICTOTEST® Reagent Tablets and Mats for Urinalysis

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ICTOTEST® Reagent Tablets and Mats for Urinalysis FDA UDI
Generic Name
Urine bilirubin IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Reagent tablets for the detection of Bilirubin in urine FDA UDI
Model / Reference
10337316 FDA UDI
Description
Reagent tablets for the detection of Bilirubin in urine FDA UDI

Identifiers

Catalog Number
A2591B24 FDA UDI
Primary DI / UDI-DI
00630414595191 FDA UDI
FDA Product Code
JJB FDA UDI
GMDN Term
Urine bilirubin IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1115 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

Yes

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 bilirubin IVD, kit, rapid colorimetric, clinical

ICTOTEST® Reagent Tablets and Mats for Urinalysis by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI a4d16f91-c77f-466d-b503-b8a7985064e8 36 fields · synced Jun 1, 2026