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Germany

H e x a l Aktiengesellschaft Betriebsstätte Oberhaching

Keltenring 1+3, 82041, Oberhaching, Germany

DAKKS D-PL-21261-01-00ISO/IEC 17025Register refreshed 2026-11-06

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Scope lines
3
DAKKS certificate
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DAKKS accredited scope

What this lab is accredited for

We found no published test standard numbers in this lab’s scope. The full scope as published is below.

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DAKKS certificate D-PL-21261-01-00 · 3 lines

LineMethodMatrixRange
1DIN EN ISO/IEC 17025:2018; DIN EN ISO 9001--
2

Extracted from the scope document; tables may not line up. View scope for the original.

Annex to the Accreditation Certificate D-PL-21261-01-00 Tests in the following areas: Healthcare (Medical Laboratory Investigations in the Context of Clinical Studies) Within the given testing field marked with *) the testing laboratory is permitted, without being required to inform and obtain prior approval from DAkkS, the free choice of standard or equivalent testing methods. Within the given testing field marked with **) the testing laboratory is permitted, without being required to inform and obtain prior approval from DAkkS, the modification, development and refinement of testing methods. The listed testing methods are exemplary. The testing laboratory maintains a current list of all testing methods within the flexible scope of accreditation. Valid from: 22.05.2024 Date of issue: 06.06.2024 This document is a translation. The definitive version is the original German annex to the accreditation certificate. Page 2 of 3
3-Human serum; Animal serum; animal vitreous humor
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Extracted from the scope document; tables may not line up. View scope for the original.

Annex to the Accreditation Certificate D-PL-21261-01-00 Testing area: Immunology Type of testing: Ligand assays** Analyte (measurement parameter) Test material (matrix) Test technique anti-Denosumab antibodies Human serum ECLIA neutralizing anti-Denosumab antibodies Human serum ECLIA neutralizing anti-Aflibercept antibodies Human serum ECLIA anti-Aflibercept antibodies Human serum ECLIA anti-Aflibercept antibodies Animal serum ECLIA neutralizing anti-Pembrolizumab antibodies Human serum ECLIA anti-Pembrolizumab antibodies Human serum ECLIA Adalimumab Human serum ELISA Denosumab Human serum ELISA Aflibercept Human serum ELISA Aflibercept Human serum ELISA Aflibercept Animal serum ELISA Aflibercept animal vitreous humor ELISA Pembrolizumab Human serum ELISA Type of testing: Cell function tests** Analyte (measurement parameter) Test material (matrix) Test technique neutralizing anti-Pegfilgrastim antibodies Human serum cell function test Testing area: Virology Type of testing: Ligand assays** Analyte (measurement parameter) Test material (matrix) Test technique SARS-CoV- 2 IgM antibodies Human serum ELISA SARS-CoV- 2 IgG antibodies Human serum ELISA Abbreviations used: DIN Deutsches Institut für Normung e.V. – German institute for standardization EN Europäische Norm – European Standard IEC International Electrotechnical Commission ISO International Organization for Standardization Healthcare (Medical Laboratory Investigations in the Context of Clinical Studies) Valid from: 22.05.2024 Date of issue: 06.06.2024 This document is a translation. The definitive version is the original German annex to the accreditation certificate. Page 3 of 3
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Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.

Location

Keltenring 1+3, Oberhaching, 82041, DE

48.03424, 11.58792

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Accreditation data refreshed from the DAKKS register on .

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