Epredia

"Gram Stain Kits – Tissue & Film Bacteria can be classified into one of two families based upon structural and compositional differences in their cell walls. Gram-positive bacteria have…

Registry build 21.09.26

“Gram Stain Kits → Tissue & Film Bacteria can be classified into one of two families based upon structural and compositional differences in their cell walls. Gram-positive bacteria have thick cell walls with high peptidoglycan content, whereas Gram-negative bacteria have thin cell walls with low peptidoglycan content. Both Gram-positive and Gram-negative bacteria stain with the dye- lake formed by Crystal Violet Solution and Gram’s Iodine Solution. However, during rinsing with Decolorizing Solution, this dye-lake is completely removed from the thin-walled Gram- negative bacteria, allowing them to be subsequently stained with Safranin O Stain Solution. The short duration of the decolorization step enables Gram-positive bacteria to retain the crystal violet dye-lake. Care should be taken when rinsing slides with Decolorizing Solution, as extended rinses can cause the crystal violet dye-lake to be removed from Gram-positive bacteria in addition to Gram-negative bacteria. Within the Tissue Kit only, tissue elements are then counterstained yellow by Tartrazine Stain Solution.”

1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code HYI
Manufacturer City Province Registered as Device types
Jinan Babio Biotechnology Co., Ltd. Jinan Shandong Manufacturer 25

Record

Regulatory record for Epredia
Listed by Richard-Allan Scientific LLC, United States
FDA product code HYI
Device type Iodine, Grams
Device class Class 1
Regulation 21 CFR 864.1850
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-09-05

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
Gram’s Iodine Solution In distribution
Lugol’s Iodine Solution In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Remel Remel, Inc. 7
Gram Stain Core Kit Ventana Medical Systems, Inc. 1
Para-Pak C&S in Biobags Meridian Bioscience, Inc. 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