Who else makes this device?

Name: o-Dianisidine (Powder) (1 x 2 g)
Brand: o-Dianisidine (Powder) (1 x 2 g)

Hematology › Biological StainsStains, Dye Powder

O-Dianisidine (Powder) (1 X 2 G)

Catalogue number 5036, listed by Helena Laboratories, Corp., United States, under Stains, Dye Powder. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Jiangxi.

Chinese manufacturers registered for FDA product code LEF
Manufacturer	City	Province	Registered as	Device types
Nanchang White Technology Co., Ltd.	Nanchang	Jiangxi	Contract manufacturer	21

Record

Regulatory record for o-Dianisidine (Powder) (1 x 2 g)
Listed by	Helena Laboratories, Corp., United States
FDA product code	LEF
Device type	Stains, Dye Powder
Device class	Class 1
Regulation	21 CFR 864.1850
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2017-03-17
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for o-Dianisidine (Powder) (1 x 2 g)
Catalogue number	Size	Status
5036		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Epredia	Richard-Allan Scientific LLC	3

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.