Diagnosticgrade – because RUO and IVDR do not fit together

This unique quality seal ensures high quality and performance of raw materials ideally suited for use in development projects for IVD

With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine high-quality products, including reliable and reproducible product performance and knowledge on product verification procedures, including documentation to meet the requirements of the IVDR:

• IVD manufacturers can obtain reagents developed and produced by myPOLS Biotec under ISO 13485.
• We offer you the quality and safety that the IVDR requires from suppliers – these are, for example, control of suppliers via quality assurance agreements, information about changes, consent to audits.
• The Johner Institute provides  structured templates for the documentation of your product verification with clear and brief explanations of how to complete them.

Both cooperation partners express with the DiagnosticGrade seal that the reagents meet the relevant requirements and thus ensure the maturity level for diagnostics.

Diagnsoticgrade facilitates the development of new IVD assay products for IVD manufacturers and enables IVDR compliance of existing kits.

Please find more information on www.diagnosticgrade.de (in german) or contact us directly. About the Johner Institut: https://www.johner-institut.de

With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine high-quality products, including reliable and reproducible product performance and knowledge on product verification procedures, including documentation to meet the requirements of the IVDR:

Introduction

Usages:
For count, isolation and cultivation of mould and yeast.

Principle:
Peptone provides the carbon and nitrogen; glucose to provide energy; potassium dihydrogen phosphate as a buffer; agar as medium coagulant; chloramphenicol inhibit the growth of bacteria; Bengal as selective antibacterial agents inhibit the growth of bacteria.

Formulation（per liter）:
Peptone 5g
Glucose 10g
Potassium dihydrogen phosphate 1g
Magnesium sulfate 0.5g
Agar 15g
Bengal 0.03g
Chloramphenicol 0.1g
Final pH 7.2 ± 0.2


How to use：
1.Suspend 31.6g in 1 L of distilled water , stirring heated to boiling until completely dissolved, dispensing flask, 121 ℃ autoclave for 15min.
2.Diluted and treated samples.

Storage: Keep container tightly closed, store in a cool, dry place, away from bright light. Storage period of 3 years.

Specifications: 250g/bottle

250g

Introduction

Usages:
For pre-enrichment of Salmonella spp.

Principle:
Peptone provide carbon and nitrogen sources to meet the needs of bacterial growth; sodium chloride maintains osmotic equilibrium; potassium dihydrogen phosphate and disodium hydrogen phosphate as buffer.

Formulation(per liter):
Peptone: 10g
Sodium chloride:5g
Disodium hydrogen phosphate:3.5g
Potassium dihydrogen phosphate: 1.5g
Final pH7.2 ± 0.2

How to use:
1. Suspend 20g of product, adding 1L of distilled or deionized water, heated to boiling stirring until completely dissolved, dispensing into flask, autoclave at 121 for 15min, set aside.
2.Diluted and treated samples.

Quality control:

Item The name and number of strain Growth Colony Color
1 Salmonella typhi CMCC (B) 50071 good Cloudy broth
2 Salmonella typhimurium CMCC (B) 50115 good Cloudy broth
3 Paratyphoid Salmonella CMCC (B) 50093 good Cloudy broth

Storage: Keep container tightly closed, store in a cool, dry place, away from bright light. Storage period of 3 years.

500g