BD Cytology Stain Kit

2 catalogue numbers from 491458, listed by Becton, Dickinson AND Company, United States, under Stains, Dye Solution. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code LEE
Manufacturer City Province Registered as Device types
B&E BIO-Technology Co., Ltd. Yantai Shandong Manufacturer 9

Record

Regulatory record for BD Cytology Stain Kit
Listed by Becton, Dickinson AND Company, United States
FDA product code LEE
Device type Stains, Dye Solution
Device class Class 1
Regulation 21 CFR 864.1850
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-05-25
Record revised 2023-11-01 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 15 to 30 °C
Distribution end date 2020-02-04

Catalogue Numbers

Catalogue numbers for BD Cytology Stain Kit
Catalogue number Size Status
491458 In distribution
491334 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Epredia Richard-Allan Scientific LLC 28
Leica Biosystems Leica Biosystems Richmond, Inc. 6
Beckmancoulter Immunotech Corp. 1
BD Non-GYN Stain Kit 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