Diagnostic BioSystems

Diagnostic BioSystems Alkaline Phosphatase Diluent prepares alkaline-phosphatase-conjugated antibodies for immunohistochemistry. It is used to dilute the labeled antibody before the…

Registry build 21.09.26

Diagnostic BioSystems Alkaline Phosphatase Diluent prepares alkaline-phosphatase-conjugated antibodies for immunohistochemistry. It is used to dilute the labeled antibody before the antibody is applied to tissue, making it an ancillary reagent in the staining sequence rather than a stain or analyzer.

The filed 100 ml variant includes a background-reducing component. In the manufacturer’s catalog, the diluent’s role is tied to antibody binding and stability: ionic strength, pH and detergents affect how the antibody binds and maintains its tertiary structure.

Listed Item

Alkaline Phosphatase Diluent (With Background Reducing Component),100 ml

Diluent Formulation

Diagnostic BioSystems describes optimal pH and stabilizing proteins as supporting tertiary-antibody stability. Sodium chloride and detergents are included to limit nonspecific binding and enable better penetration of tertiary antibodies. These formulation roles distinguish the AP diluent from the alkaline-phosphatase enhancer and substrate/chromogen reagents used at other stages.

30manufacturers in China registered for this device type
62catalogue 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 Diagnostic BioSystems
Listed by Diagnostic Biosystems, United States
FDA product code PPM
Device type General Purpose Reagent
Device class Class 1
Regulation 21 CFR 864.4010
Establishment Remanufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2026-06-05

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

Catalogue Numbers

Catalogue numbers for Diagnostic BioSystems
Catalogue number Size Status
K024 In distribution
K028 In distribution
K076-1000 In distribution
K004 In distribution
K053-25 In distribution
K108 In distribution
K030 In distribution
M006 In distribution
K048-S In distribution
K020-NI In distribution
K033-S In distribution
K048 In distribution
K045 In distribution
K067-125AN In distribution
K042 In distribution
K023-S In distribution
K013-200 In distribution
K046-10 AN In distribution
K047C-1 L In distribution
K024-S In distribution
K009 In distribution
K065 In distribution
FD001-100 In distribution
K098-S In distribution
K095 In distribution
K076-200 In distribution
K033 In distribution
K020 In distribution
K011-S In distribution
K048-200 In distribution
K056-S In distribution
K095-S In distribution
K082-S In distribution
K023-NC-1L In distribution
K011 In distribution
K076 In distribution
K023 In distribution
K076-S In distribution
K098 In distribution
K093 In distribution
K053-100 In distribution
K046-50 In distribution
K046 In distribution
K087-500-HL In distribution
K094-100-HL In distribution
K088-500-HL In distribution
K022 In distribution
K024-1L In distribution
K108-10 In distribution
K053-06 In distribution
K100-S In distribution
K004-S In distribution
K045-S In distribution
K082 In distribution
K024-200 In distribution
07342098001 In distribution
K028-NI In distribution
K056-100AN In distribution
K093-S In distribution
K100 In distribution
K013 In distribution
K039 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Epredia Richard-Allan Scientific LLC 59
Alpha-Tec Systems Alpha-Tec Systems, Inc. 46
Vysis Abbott Molecular, Inc. 34
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