Genemed®

Power-Stain™ 1.0 Double Stain (Poly HRP for Mouse + Poly AP for Rabbit), Ready-To-Use, 15 mL

Registry build 21.09.26
30manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (6), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PPM
Manufacturer City Province Registered as Device types
Takara Biotechnology (Dalian) Co., Ltd. Dalian Liaoning Contract manufacturer 1
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Zhejiang Gene Science Co., Ltd. Shaoxing Zhejiang Manufacturer 31
Biomed Plastics Co. Taicang Jiangsu Contract manufacturer 29
Jinan Babio Biotechnology Co., Ltd. Jinan Shandong Manufacturer 25
AVE Science & Technology Co., Ltd. Changsha Hunan Manufacturer 22
Bioteke Corporation (Wuxi) Co., Ltd. Wuxi Jiangsu Manufacturer 21
Shenzhen Yhlo Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 19
Wuhan Landing Intelligence Medical Co., Ltd. Wuhan Hubei Manufacturer 17
Shanghai FLY Medical Devices Co., Ltd. Minhang District Shanghai Manufacturer 15
Medico Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 11

Showing 12 of 30. All 30 manufacturers in China registered for General Purpose Reagent

Record

Regulatory record for Genemed®
Listed by Sakura Finetek U.S.A., Inc., United States
FDA product code PPM
Device type General Purpose Reagent
Device class Class 1
Regulation 21 CFR 864.4010
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-12-28
Record revised 2023-06-02 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Genemed®
Catalogue number Size Per pack Status
10-0040 In distribution
10-0048 In distribution
54-0022 In distribution
10-0033 In distribution
10-0047 In distribution
10-0032 In distribution
52-0003 In distribution
10-0037 In distribution
52-0006 In distribution
10-0058 In distribution
10-0022 In distribution
10-0005 In distribution
54-0006 In distribution
10-0046 In distribution
10-0045 In distribution
10-0041 In distribution
10-0034 In distribution
52-0017 In distribution
10-0044 2 In distribution
10-0027 In distribution
52-0022 In distribution
10-0029 In distribution
10-0039 In distribution
10-0028 In distribution
54-0003 In distribution
52-0020 In distribution
10-0176 In distribution
10-0001 In distribution
54-0017 In distribution
10-0056 In distribution
10-0024 In distribution
10-0020 In distribution
52-0023 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Diagnostic BioSystems Diagnostic Biosystems 62
Epredia Richard-Allan Scientific LLC 59
Alpha-Tec Systems Alpha-Tec Systems, Inc. 46
Vysis Abbott Molecular, Inc. 34
Edge Biologicals Inc Edge Biologicals, Inc. 25
Immunalysis Immunalysis Corporation 22
Fisherbrand Fisher Scientific Company L.L.C. 22
Bond Leica Biosystems Newcastle Ltd 16
Vitros Ortho-Clinical Diagnostics, Inc. 16
Synchron Beckman Coulter, Inc. 13
Immy Immuno-Mycologics, Inc. 12
Tissue-Tek Genie® Sakura Finetek U.S.A., Inc. 11

Showing 12 of 617. All products under General Purpose Reagent

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