Vysis

Vysis IntelliFISH Universal FFPE Tissue Pretreatment Protease (For 500 mL)

Registry build 21.09.26
30manufacturers in China registered for this device type
34catalogue 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 Vysis
Listed by Abbott Molecular, Inc., United States
FDA product code PPM
Device type General Purpose Reagent
Device class Class 1
Regulation 21 CFR 864.4010
Establishment Specification developer, Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-04-25
Record revised 2019-10-23 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature -25 to -15 °C

Catalogue Numbers

Catalogue numbers for Vysis
Catalogue number Size Status
08N87-005 In distribution
07J05-001 In distribution
07J03-005 In distribution
06J93-001 In distribution
07J02-002 In distribution
06J49-010 In distribution
02J02-032 In distribution
02J10-032 In distribution
01N99-001 In distribution
07J02-003 In distribution
06J67-001 In distribution
06J50-001 In distribution
07J04-001 In distribution
07J81-001 In distribution
07J83-001 In distribution
07J04-005 In distribution
06J67-011 In distribution
06J29-010 In distribution
06J49-001 In distribution
07J00-001 In distribution
07J82-001 In distribution
08N87-001 In distribution
06J29-001 In distribution
06J40-020 In distribution
06J31-001 In distribution
06J40-010 In distribution
07J06-001 In distribution
02J08-032 In distribution
07J84-001 In distribution
08N85-005 In distribution
08N85-015 In distribution
08N85-010 In distribution
07J03-001 In distribution
02J03-032 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
Genemed® Sakura Finetek U.S.A., Inc. 33
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