← Back to catalogue

o-Tolidine (Powder) (1 x 2 g)

FDA UDI

Class I (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
o-Tolidine (Powder) (1 x 2 g) FDA UDI
Generic Name
Protein electrophoresis IVD, reagent FDA UDI
Model / Reference
5041 FDA UDI

Identifiers

Primary DI / UDI-DI
M52550410 FDA UDI
FDA Product Code
IAB FDA UDI
GMDN Term
Protein electrophoresis IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1850 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

Yes

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: Protein electrophoresis IVD, reagent

o-Tolidine (Powder) (1 x 2 g) by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Protein electrophoresis IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Helena Laboratories, Corp.

Sources (1)

  • FDA UDI fb002b2b-1547-475f-83cb-d6f27b757bda 33 fields · synced Jun 9, 2026