QuanTtest Red Pyrogallol Red Reagent

FDA UDI

Class II (US FDA UDI)

by Quantimetrix Corp.

Identity

Trade Name: QuanTtest Red Pyrogallol Red Reagent FDA UDI
Generic Name: Total protein IVD, reagent FDA UDI
Device Name: QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems. FDA UDI
Model / Reference: 5210-12 FDA UDI
Description: QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems. FDA UDI

Identifiers

Catalog Number: 5210-12 FDA UDI
Primary DI / UDI-DI: M0515210120 FDA UDI
510(k) Number: K904603 FDA UDI
FDA Product Code: CEK FDA UDI
GMDN Term: Total protein IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1635 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total protein IVD, reagent

QuanTtest Red Pyrogallol Red Reagent by Quantimetrix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K904603 also covers:

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

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Manufacturer

Manufacturer: Quantimetrix Corp.

Sources (1)

FDA UDI 037a9f90-8d4e-46fe-a0bc-e8acd46cdb4d 37 fields · synced Jun 1, 2026