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IVD SUPPLIES AND MATERIALS

IVD Supplies & Materials for In Vitro Diagnostic Industry 

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Lateral Flow Membranes

Nitrocellulose membranes
Antibody-&-Antigen

Antibody & Antigen

For lateral flow applications
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Colloidal Gold

Key components for lateral flow assay
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Microplate Filling

A good device for ELISA kit manufacturing
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Conjugate & Sample Pad

For lateral flow applications
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Cardboard

PVC or PS baking cardboard
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Strip Cutter

A good device for ELISA kit manufacturing
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Cassette Assembling Machine

Automated assembling the strips into cassette
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Laboratory Reagent Dispenser

Exactly dispensing liquids on the strips

In Vitro Diagnostics

In Vitro Definition

IVD, as an independent branch of medical devices, has its own unique definition and regulatory system, especially the US Food and Drug Administration (FDA) and European Union (EC). IVD mainly includes instruments, reagents or systems for in vitro diagnostics. However, the situation in China is different. IVD is not independently distinguished and defined, that is, there is no concept of IVD. The products included in the international IVD concept are broken down and belong to medical devices (MD), in vitro diagnostic reagents (IVD Reagents) and medicines.

In China, except for in vitro diagnostic reagents for blood source screening and the use of radionuclide-labeled in-vitro diagnostic reagents that are defined as drug management, all other IVD products are under medical device (MD)

In Vitro Diagnostic Test

There are some types of IVD diagnostics: Biochemical diagnostic reagents, immunodiagnostic reagents, molecular diagnostic reagents, microbiological diagnostic reagents, urine diagnostic reagents, coagulation diagnostic reagents, hematology, flow cytometric diagnostic reagents and Lateral Flow Immunodiagnostic, etc.
There are lots of Lateral Flow IVD test kit widely used in our daily life. Easy to buy amazon, ebay, drug store, supper market, etc. For example:

For Human Being:

FDA Approved Home Cholesterol Test Kit
HCG test for pregnancy
LH test for ovulation detection
HIV Test strip
Malaria Test strip
... ...

For Food Safety:

Antibiotics Test
Honey Test
Fishing Test
Test kit for detecting drug residues in egg, meat, milk, fish, rice, etc.

For Animal Health:

Test kit for detecting diseases in cattle, dog, cat, goat, sheep, etc.

Top 25 diagnostic companies

Alere Inc.
Arkray
Beckman Coulter / Danaher
Becton Dickinson
Bio-Rad Laboratories
bioMérieux
Cepheid / Danaher
Danaher Corp. (including Radiometer A/S)
Grifols
Hologic
Illumina
Instrumentation Laboratory / Werfen
LabCorp, Laboratory Corporation of America
Luminex
Ortho Clinical Diagnostics
PerkinElmer
Qiagen N.V.
Quest Diagnostics
Quidel
Roche Diagnostics (including Ventana Medical Systems)
Philips
Siemens Healthineers
Sysmex Corporation
Thermo Fisher Scientific

BALLYA work in Lateral Flow Immunodiagnostic research & development more than 12 years. Especially in Colloidal gold & Fluorescence platform, we had launched 8 types test kit basic on both platform. We focus on food safety test kit, but also pay more attention and research in IVD medical devices for human beings.

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