H e x a l Aktiengesellschaft Betriebsstätte Oberhaching
Keltenring 1+3, 82041, Oberhaching, Germany
- Scope lines
- 3
- DAKKS certificate
- 1
- Site in our directory
- 1
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.
Only this lab. Searches the method, matrix and range of each of the 3 scope lines.
DAKKS certificate D-PL-21261-01-00 · 3 lines
| Line | Method | Matrix | Range |
|---|---|---|---|
| 1 | DIN 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 humorShow page textExtracted 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 | - |
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
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Accreditation data refreshed from the DAKKS register on .
This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the DAKKS entry linked above.