Epredia

"The Acid Fast Bacillus Stain Kit (87016) and components are for use as a kit in special stain techniques to detect acid fast bacteria. A waxy, lipid-rich cell wall surrounds the acid fast…

Registry build 21.09.26

“The Acid Fast Bacillus Stain Kit (87016) and components are for use as a kit in special stain techniques to detect acid fast bacteria. A waxy, lipid-rich cell wall surrounds the acid fast bacterium. This cell wall absorbs carbol fuchsin but is resistant to decoloration with acid alcohol. Bacteria that do not have a lipid-rich cell wall easily decolorize leaving the acid fast bacillus. Loeffler Methylene Blue Stain Solution provides a light blue counterstain to provide contrast for surrounding tissue elements from the brick red acid fast bacillus.”

1manufacturer
1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code ICL
Manufacturer City Province Registered as Device types
Zhejiang Gene Science Co., Ltd. Shaoxing Zhejiang Manufacturer 31

Record

Regulatory record for Epredia
Listed by Richard-Allan Scientific LLC, United States
FDA product code ICL
Device type Carbol Fuchsin
Device class Class 1
Regulation 21 CFR 864.1850
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-08-07

Specifications

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

Catalogue Numbers

Catalogue numbers for Epredia
Catalogue number Size Status
Carbol Fuchsin Solution In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alpha-Tec Systems Alpha-Tec Systems, Inc. 5
Remel Remel, Inc. 2
Rowley Biochemical Carbol Fuchsin Transene Company, Inc. 1
Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution Transene Company, Inc. 1
AFB III Staining Kit Ventana Medical Systems, Inc. 1
BD BBL™ TB Carbolfuchsin ZN Becton, Dickinson AND Company 1
BenchMark Special Stains AFB Staining Kit Ventana Medical Systems, Inc. 1
Rowley Biochemical Kinyoun’s Carbol Fuchsin Solution Transene Company, Inc. 1
BD BBL™ TB Carbolfuchsin KF Becton, Dickinson AND Company 1

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer