ProtoFluor Reagent (2x15 mL)

FDA UDI

Class I (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name: ProtoFluor Reagent (2x15 mL) FDA UDI
Generic Name: Protoporphyrin IX IVD, reagent FDA UDI
Model / Reference: 2002 FDA UDI

Identifiers

Primary DI / UDI-DI: M52520020 FDA UDI
510(k) Number: K893038 FDA UDI
FDA Product Code: JKJ FDA UDI
GMDN Term: Protoporphyrin IX IVD, reagent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1595 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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: Protoporphyrin IX IVD, reagent

ProtoFluor Reagent (2x15 mL) by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Protoporphyrin IX IVD, reagent.

ProtoFluor Reagent System (Part 1 of 2) — Helena Laboratories, Corp. · Class I
ProtoFluor Glass Slides — Helena Laboratories, Corp. · Class I
ProtoFluor Reagent System (Part 2 of 2) — Helena Laboratories, Corp. · Class I

Cleared under the same submission

K893038 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 I	Pending data

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Manufacturer

Manufacturer: Helena Laboratories, Corp.

Sources (1)

FDA UDI 53e521bf-8539-4884-8bfd-ab8dd14acb5f 34 fields · synced Jun 9, 2026